Abstract
Aim:
This study investigated the effect of supplemental feeding tube device (SFTD) method on time to transition to exclusive breastfeeding and discharge time in preterm infants.
Methods:
This randomized controlled trial was conducted in the neonatal intensive care unit of a public hospital in Turkey (Clinical Trial Number: NCT05815706). The sample consisted of 65 preterm infants randomized into a control (n = 32) and an experimental (n = 33) group. The experimental group participants were SFTD-fed until they switched to exclusive breastfeeding. The control group participants were fed according to the routine procedure. Data were collected using a questionnaire, a Preterm Infant Monitoring Form, and the LATCH Breastfeeding Assessment Tool. The data were analyzed using numbers, percentage distributions, means, standard deviations, Pearson’s chi-square test, and independent samples t-test. The study was approved by an Ethics Committee. Permission was obtained from the hospital. Informed consent was obtained from all parents.
Results:
The experimental group (123.64 ± 63.25 hours) demonstrated an earlier transition to exclusive breastfeeding compared with the control group (187.50 ± 95.30 hours) (p < 0.05). The experimental group (361.45 ± 110.46 hours) had significantly shorter hospital stays than the control group (479.25 ± 163.17 hours). The experimental group (35.33 ± 1.14 weeks) had a significantly younger gestational age at discharge than the control group (35.97 ± 1.03 weeks).
Conclusion:
The SFTD is an alternate supportive feeding method that helps preterm infants switch to exclusive breastfeeding sooner, have shorter hospital stays, and have a younger gestational age at discharge than their bottle-fed counterparts.
Introduction
Preterm infants transitioning from gavage to oral feeding are initially unable to fully feed at the breast.1,2 Therefore, alternative supplemental feeding methods (bottle, spoon, dropper, cup, breastfeeding support system, and finger feeding) need to be used until preterm infants mature enough that they are able to meet their daily nutritional needs by breastfeeding alone.2–5 It is necessary to identify the most effortless and least harmful method of supplementing breastfeeding for each mother ready to breastfeed her preterm infant. 2
In 1991, the WHO and UNICEF launched the Baby-Friendly Hospital Initiative (BFHI). This specified “Ten Steps to Successful Breastfeeding.” The revised BFHI Implementation Guidance document (2018) expanded the interpretation of these Ten Steps to include a distinct group of special infants (small, sick, and/or preterm infants). The newly revised Step Nine of the BFHI advises to “counsel mothers on the use and risks of feeding bottles, teats, and pacifiers”. 6 The bottle-feeding is not recommended for breastfed preterm infants2,3,7,8 because research has shown that bottle-feeding prevents them from developing sucking skills.4,9,10 Hospital initiatives have recommended alternative supplementary feeding methods for breastfeeding infants instead of using bottles or artificial nipples. 8 Supplemental feeding methods can include cup-feeding, syringes, finger-feeding, spoon-feeding, and supplemental feeding tube devices (SFTDs). Previous research has highlighted the advantages and disadvantages of cup-feeding, syringes, finger-feeding, and spoon-feeding. Mirzai et al. 11 examined the effect of cup-feeding and finger-feeding on weight gain in preterm infants and reported two significant results. First, both cup-feeding and finger-feeding groups gained significantly more weight than the control group. Second, finger-feeding was more effective for gaining weight and achieving independent oral feeding than cup-feeding. 11 Buldur et al. 12 compared syringe and finger-feeding in supporting sucking skills in preterm infants. They found that the finger-feeding group had a faster transition to breastfeeding, a higher comfort level, and a shorter hospital stay than the syringe group. 12 Aytekin et al. 4 compared bottle-feeding and spoon-feeding in preterm infants. They determined that the spoon-fed infants switched to full breastfeeding sooner than the bottle-fed infants. 4 However, some disadvantages of these complementary feeding methods include breast milk/formula loss (spillage), oromotor movements different from breastfeeding, slower feeds, and limited mother–baby contact.2,4,12
An SFTD helps preterm infants meet their nutritional needs and develop sucking skills while promoting mother–infant interaction and attachment.2,7,13,14 The BFHI recommends using an SFTD as an alternative feeding method for term and late preterm infants. The report also stresses the superior features of SFTDs, such as supporting infants’ sucking skills, enabling measurement of food intake, and infant-led feeding. 2 Penny et al. 8 argue that there is little research on alternative feeding methods and a gap in the literature on the impact of SFTDs on breastfeeding. Since Penny’s work, two randomized controlled trials (RCTs) have investigated the effect of SFTDs on preterm infants’ sucking skills, transition to exclusive breastfeeding, discharge, and related variables.13,14 Celik et al. 14 recruited 70 preterm infants and divided them into experimental (n = 35) and control (n = 35) groups. The experimental group received oral motor stimulation (OMS) combined with an SFTD. The experimental group (OMS+SFTD) switched to oral feeding and exclusive breastfeeding sooner than the control group. 14 However, this result does not provide information regarding what effect an SFTD would have when applied alone. Calikusu Incekar et al. 13 recruited 46 infants and divided them into two groups: SFTD (n = 23) and bottle-feeding (n = 23). The findings indicate that, despite participants in the SFTD group transitioning to exclusive breastfeeding and being discharged earlier than those in the bottle-feeding group, the observed difference was not statistically significant. 13 Consequently, further research is warranted to explore this topic more comprehensively.
Managing the transition to breastfeeding for preterm infants in neonatal intensive care units (NICUs) is critical. 2 Due to breastfeeding difficulties, mothers of preterm infants face several challenges that result in lower breastfeeding rates. 12 When health care professionals implement policies that support breastfeeding, even the smallest preterm infant can be breastfed. 2 This study investigated the effect of SFTD method on the time to transition to exclusive breastfeeding, and the time to discharge in preterm infants.
We hypothesized that (1) the experimental group would transition to exclusive breastfeeding sooner than the control group and (2) have shorter hospital stays.
Materials and Methods
Study design and setting
This was a parallel-group randomized-controlled trial that was conducted between 20 November 2018 and 30 April 2019 at a NICU of a public hospital in a provincial center in eastern Turkey. Ethics approval was obtained from the Clinical Research Ethics Committee of the Atatürk University (Date: January 04, 2018; Document ID: 2018-1/20), and the study was recorded in the clinicaltrials.gov PRS system (ID: NCT05815706). Informed consent was obtained from all the mothers, and the trial was conducted in accordance with the Declaration of Helsinki. The study adhered to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. 15
Inclusion criteria. The preterm infants were eligible to participate if they met the following criteria: (1) being between the gestational ages of 30 to 34 weeks, (2) having a birthweight of ≥1000 g, (3) having an APGAR score of >6, (4) having stabilized for 48 hours after receiving mechanical ventilator or continuous positive air pressure or both, (5) being exclusively gavage-fed with breast milk and/or formula and ready to switch to oral feeding, and (6) being mother’s willingness to breastfeed.
Exclusion criteria. The preterm infants (1) having a congenital malformation that may cause asphyxia and affect breathing, (2) having an intraventricular hemorrhage, intracranial hemorrhage, or periventricular leukomalacia, (3) having intestinal anomalies or hyperbilirubinemia requiring exchange transfusion, and (4) having respiratory distress syndrome, bronchopulmonary dysplasia, or other chronic lung diseases.
Sample size and randomization
A prior power analysis (G*Power 3.1.7) was performed to determine the sample size. In Kaya and Aytekin 1 study, a difference in LATCH Breastfeeding Assessment Tool scores of between 6.83 (SD = 1.27) and 7.85 (SD = 0.92) points was found to be statistically significant. The effect size of 0.91 was calculated for this study. The sample size was determined to be 64, with 32 in each group, a margin of error of 0.05, and a statistical power of 95%. Considering the possibility of losses in the sample over time, 12.5% more participants were included in the study (the total sample size is a multiple of the block size). The study was carried out with 72 preterm infants, 36 in the experimental group and 36 in the control group. Seven preterms were excluded from the study because they were transferred to another NICU or their mothers withdrew from the study (ncontrol = 4, nexperimental = 3). Therefore, the final sample consisted of 65 preterm infants (Fig. 1).

Flow diagram of study.
Research shows that gestational age and breastfeeding skills affect the sucking behavior of preterm infants.1,16 Therefore, gestational age (30–32 and 33–34 weeks), gender (girls and boys), and LATCH Tool scores (0–2, 3–6, and 7–10 points) were used for block randomization. The blocks were repeated three times in each group. Thirty-six participants were assigned to each group. A 2 × 2 × 3 × 3 blocked randomization list was developed using an online randomization tool. 17 The researcher was an NICU worker. She was in the NICU five days a week between 08:00 and 17:00. She found out which group each infant was in just before the intervention. Another researcher performed the randomization. The study groups were coded as A and B to avoid statistical bias and statistical blinding was performed. The participants were not compensated.
Intervention
The participants were informed about the feeding methods. Each participant only found out which group she had been placed in after the intervention started. The data were collected face-to-face through interviews, observations, and follow-ups. The researcher interviewed the mothers and checked the participants’ files to fill out the questionnaire. LATCH was scored during the first breastfeeding (before bottle/STFD method was started) by the researcher and the volunteer observer through observation. The researcher monitored each participant until discharge and recorded the information on the form. Before the first feeding each day (09.00), the researcher weighed each infant and recorded their body weight on the form. All participants were fed according to the NICU feeding protocol.
Clinical feeding protocol
A preterm infant switching from gavage to oral feeding was breastfed, followed by bottle-feeding. The bottle was filled with either breast milk or formula. A neonatologist calculated the required amount of breast milk/formula according to the daily nutritional needs of the preterm infant. The bottle was heated to body temperature in the heating device. After the preterm infant had sucked on the mother’s breast (15–20 minutes), they were bottle-fed (10–15 minutes) by their mother. Late preterm infants were fed eight meals a day (at 09:00, 12:00, 15:00, 18:00, 21:00, 00:00, 03:00, and 06:00). The NICU did not use SFTDs in routine practice.
The experimental group participants were fed using the commercial SFTD, which consisted of a syringe/container and a feeding catheter. One end of the feeding probe was located in the syringe/container, while the other was fixed to the mother’s nipple using a plaster. The SFTD was a sterile product with an adjustable breast milk flow system and neck strap. It was bisphenol A-free. All its parts were in direct contact with breast milk. The SFTD allowed the baby to both suck and feed. The control group participants were fed using sterile and latex-free bottles with narrow mouths suitable for preterm infants. A bottle warmer, a bottle sterilizer, a baby scale, and a clock were also used in the study.
For the participants in the experimental group, the SFTD was used at all feeding meals on one day. Since the researcher worked in the NICU between 08:00 and 17.00, she followed the mothers and babies for only three feedings. At the other feedings, the unit nurses followed the mothers and infants. To enable them to do this successfully, the researchers trained the nurses and the experimental group mothers about SFTD-feeding before the study.
The control group participants were bottle-fed according to the clinical feeding protocol. Skin-to-skin contact was limited to the duration of breastfeeding. The infants were in their mothers’ arms during the bottle-feeding after breastfeeding. They were not SFTD-fed.
The experimental group participants were breastfed for 10 minutes (5 minutes for each breast) every day from the day they started oral feeding until they switched to exclusive breastfeeding. The nurse placed the warmed breast milk or formula in the SFTD. She then fixed the device to the mother’s nipples. Each experimental group participant sucked on the two breasts for 15 minutes. Breastfeeding (ten minutes), resting and SFTD preparation (5minutes), and SFTD-feeding (15 minutes) were limited to a total of 30 minutes in light of earlier research.18–20
Measurements
A questionnaire was used to collect data regarding the descriptive characteristics of the preterm infants and their mothers. The questionnaire was based on a literature review conducted by the researchers.1,4,16
The first breastfeeding skills were assessed using LATCH at the transition to oral feeding with reference to earlier research.1,16 The LATCH Breastfeeding Assessment Tool was developed by Jensen et al. 21 and adapted to Turkish by Yenal and Okumus. 22 LATCH is a diagnostic tool with an easy scoring system similar to the APGAR scoring system.21,22 It consists of five evaluation criteria: L (Latch on breast), how well the infant latches onto the breast; A (Audible swallowing), the amount of audible swallowing noted; T (Type of nipple), the mother’s nipple type; C (Comfort, breast/nipple), the mother’s level of comfort in relation to the nipple; and H (Hold/Help), the amount of help the mother needs to hold her infant to the breast. Each item is rated on a scale of 0–2. The total score ranges from 0 to 10, with higher scores indicating more successful breastfeeding. 22 The Turkish version had a Cronbach’s alpha of 0.95, 22 which was 0.76 in the present study. The researcher and a volunteer observer nurse filled out LATCH for each participant simultaneously but independently from each other at first breastfeeding. Inter-rater reliability was measured using Kappa statistics for the agreement between the two independent observers. The inter-rater reliability was near perfect. 23 Infants who switched to oral feeding experienced their first feeding by sucking on the mother’s breast. Meanwhile, LATCH was scored before bottle/STFD feeding. No different feeding method was used.
The researchers developed the Preterm Infant Monitoring Form to record the participants’ transition to oral feeding, transition to exclusive breastfeeding, discharge time, body weight, and gestational age at these stages.
The primary outcomes were the transition time to exclusive breastfeeding, discharge time, and body weight and gestational age at these periods. The feeding categories were defined according to the WHO’s 2021 definition of breastfeeding. “Exclusive breastfeeding” is characterized by the sole use of the mother’s milk, without any additional liquids or solids from external sources entering the infant’s mouth, except for vitamins and minerals. The use of bottles encompasses feeding human milk, formula, or other liquid foods to the infant from a bottle. 24
The time to transition to exclusive breastfeeding is between the start of oral feeding and the transition to exclusive breastfeeding. Three criteria were set for the transition to exclusive breastfeeding in light of earlier research: the preterm infant (1) has been fed at a volume of at least 120 mL/kg/day for more than eight oral feeds, (2) has not received gavage feeding supplements for 48 hours, and (3) has displayed adequate weight gain.25,26 Discharge time is the time between admission and discharge. Body weight at the transition to exclusive breastfeeding is the body weight at the time of transition to exclusive breastfeeding. Body weight at discharge is the body weight of the preterm infant at discharge. Gestational age at the transition to exclusive breastfeeding is the gestational age at the time of transition to exclusive breastfeeding. Gestational age at discharge is the gestational age of the preterm infant at discharge.
The secondary outcomes were time to transition to oral feeding, body weight and gestational age at this period, and gestational age at first breastfeeding. The time to transition to oral feeding is when the preterm infant switches from gavage feeding to oral feeding (bottle/SFTD). According to the unit’s procedures, the team (physician, nurse, etc.) decided whether a preterm infant should be switched to oral feeding. Body weight at the transition to oral feeding is the body weight at the transition from gavage feeding to oral feeding. Gestational age at the transition to oral feeding is the gestational age at the transition from gavage feeding to oral feeding. Gestational age at the first breastfeeding is the gestational age at the time of transition at the first breastfeeding.
Variables related to time were presented in hours, those related to body weight were presented in grams, while those related to gestational age were presented in weeks.
Data analysis
The data were analyzed using the Statistical Package for Social Sciences (SPSS Inc., Chicago, IL, USA) for Windows (version 25.0). Baseline characteristics and outcome variables were compared using numbers, percentage distributions, means, and standard deviations. Normality was tested using Kurtosis and Skewness coefficients. Pearson’s chi-square tests were performed to compare differences between groups. Independent samples t-tests were conducted to compare continuous normally distributed variables (the time to transition to exclusive breastfeeding, and the time to discharge). The effect size and confidence intervals were calculated. Cohen’s d formula was used to calculate the effect size. Cronbach’s alpha was calculated to test the internal consistency of LATCH. Kappa analysis was used to estimate the agreement between the two independent observers. A p value <0.05 was considered statistically significant.
Results
The participants (n = 65) had a mean gestational age of 33.15 ± 1.18 weeks (min:30; max:34 weeks). The control and experimental groups had similar baseline characteristics. There was also no significant difference in LATCH scores at first breastfeeding between the control and experimental groups. Baseline data are shown in Table 1.
Comparison of Descriptive Characteristics of the Control and Experimental Groups
χ2, Pearson’s Chi-square analysis; t, Independent groups t-test; SD, Standard deviation.
Table 2 compares the control and experimental groups in terms of the characteristics of discharge and the transition to oral feeding and exclusive breastfeeding. The experimental group (123.64 ± 63.25 hours) switched to exclusive breastfeeding significantly sooner than the control group (187.50 ± 95.30). The effect size was 0.789 (medium). The experimental group (361.45 ± 110.46 hours) had a significantly shorter time to discharge than the control group (479.25 ± 163.17 hours). The effect size was 0.845 (large) (Table 2).
Comparison of the Control and Experimental Groups in Terms of the Characteristics of Discharge and the Transition to Oral Feeding and Exclusive Breastfeeding
Significant difference p < 0.05 is marked in bold.
Wk, week; h, hour; g, gram; CI, confidence intervals.
The groups had no significant differences in mean body weight at the transition to exclusive breastfeeding, and discharge. The groups had no significant differences in the gestational age at transition to exclusive breastfeeding. However, the experimental group (35.33 ± 1.14 weeks) had a significantly younger gestational age at discharge than the control group (35.97 ± 1.03 weeks) (p < 0.05). The effect size was 0.589 (medium) (Table 2).
There was no significant difference in the time to transition to oral feeding between the groups (p > 0.05). The groups had no significant difference in mean body weight at the transition to oral feeding. The groups had no significant difference in the gestational age at transition to oral feeding and first breastfeeding (Table 2).
Discussion
Research shows that preterm infants can latch on, suck and swallow, and achieve exclusive breastfeeding at earlier gestational ages than previously thought. 27 Alternative supportive feeding methods are needed to provide milk to small, sick, and/or preterm infants who cannot initially be fully breastfed. 2 However, there is little research on the effects of alternative feeding practices on preterm infants during the transition to oral feeding.4,5,9,12,28 As a result, there is no guidance on appropriate feeding practices. Research shows that cup-feeding is more effective than bottle-feeding in helping preterm infants transition to exclusive breastfeeding.9,28,29 Rocha et al. 28 found that cup-fed infants had fewer desaturation episodes and higher breastfeeding rates than bottle-fed infants. Aytekin et al. 4 investigated the effect of bottle-feeding and spoon-feeding methods on the timing of the transition to exclusive breastfeeding and suckling success in preterm infants. They reported that spoon-fed infants transitioned to exclusive breastfeeding earlier than their bottle-fed counterparts.
Alternatives to breastfeeding may not be benign. For example, research has shown that bottle-feeding has a negative impact on the transition to breastfeeding and the sucking success of preterm infants.3,5,30,31 Bottle-feeding is associated with lower oxygen saturation, lower temperatures, and more desaturation episodes than breastfeeding or cup-feeding in preterm infants.28,29 Allen et al. 3 claim that bottle avoidance increases the extent of exclusive breastfeeding at discharge and increases exclusive breastfeeding six months after discharge in preterm infants.
Lactation consultants and nurses widely accept the use of SFTDs, but we lack evidence to fully understand their effectiveness. Therefore, more research is needed to help nurses working with preterm infants make informed decisions about alternative supplemental feeding methods. Researchers have also emphasized the need for further research due to the lack of scientific evidence regarding the effectiveness of SFTDs.3,5,29 In this study, the effects of SFTD feeding and bottle-feeding on weight gain, transition to breastfeeding, and length of hospital stay were compared. The results showed that SFTD-fed infants transitioned to exclusive breastfeeding sooner, had shorter hospital stays, and had discharge at younger gestational weeks than bottle-fed infants.
Only two randomized controlled trials have examined the benefits of SFTDs for NICU preterm infants.13,14 Celik et al. 14 recruited 70 preterm infants and divided them into experimental (n = 35) and control (n = 35) groups. The experimental group received oral motor stimulation (OMS) combined with an SFTD. The experimental group (OMS+SFTD) transitioned to oral feeding and exclusive breastfeeding earlier than the control group. However, this result does not indicate what effect an SFTD would have if used alone. Calikusu Incekar et al. 13 compared the effect of an SFTD and bottle-feeding on weight gain, transition to exclusive breastfeeding, sucking success, and duration in preterm infants. They divided 46 infants into SFTD (n = 23) and bottle-feeding (n = 23) groups. The results showed that although the SFTD group transitioned to exclusive breastfeeding and had shorter hospital stays than the bottle-feeding group, the difference was insignificant. The researchers thus recommended further research on this topic. The present study is the first randomized controlled trial to prove that SFTDs help preterm infants switch to exclusive breastfeeding sooner, be discharged at younger gestational weeks, and have shorter hospital stays than bottle-fed preterm infants.
An SFTD is ideal for giving supplementary nutrients while performing simple breastfeeding movements in preterm infants. 32 The participants in the experimental group in the present study had more extended skin-to-skin contact with their mothers while breastfeeding followed by SFTD-feeding, resulting in increased mother–infant interaction. The infants gained more sucking experience to develop feeding skills. They received the complementary food by performing the same oromotor movements as in breastfeeding and increased milk production by sucking on the mother’s breast. As both the preterm and the mother in the experimental group progressed toward a more satisfactory breastfeeding experience, the preterm infant switched to exclusive breastfeeding in a shorter time, had a younger gestational age, and was discharged from the hospital in a shorter time.
This study had two limitations. First, blinding was not possible due to the nature of the research. However, to reduce researcher bias, a blinded observer scored each participant’s breastfeeding skills (LATCH). Additionally, statistical blinding was performed. Second, the researcher observed participants only during weekday working hours during three SFTD/bottle-assisted feeding sessions (9:00, 12:00, and 15:00.). Different neonatal nurses monitored participants at other mealtimes and on weekends.
Conclusion
SFTD-fed preterm infants transition to exclusive breastfeeding sooner, have shorter hospital stays, and are discharged at younger gestational weeks than their bottle-fed counterparts. This is the first RCT to prove that SFTDs help preterm infants switch to exclusive breastfeeding sooner, be discharged at younger gestational weeks and have shorter hospital stays than bottle-fed preterm infants. We recommend that NICU health care professionals consider using SFTDs as an alternative supportive feeding method to help preterm infants transition to exclusive breastfeeding sooner.
Footnotes
Acknowledgment
The authors would like to thank all the participants and their parents.
Authors’ Contributions
C.A.: Conceptualization, Methodology, Software, Data curation, and Writing—original draft; A.A.O.: Conceptualization, Methodology, Software, Data curation, Supervision, and Writing—review and editing; H.K.: Conceptualization, Methodology, Software, Data curation, and Writing—original draft.
Disclosure Statement
No competing financial interests exist.
Funding Information
No funding was received for this article.
