Comparison of Paladai Cup Against Nifty Cup Feeding in Preterm Low-Birth-Weight Infants: An Open-Labeled Randomized Controlled Trial

Abstract

Background:

Neonatal Intuitive Feeding Technology (NIFTY) cup feeding has been found to be feasible in preterm low-birth-weight babies. However, literature on direct comparison of the same with paladai feeding is lacking.

Methods:

In this open-labeled, randomized controlled trial, preterm infants (<34 weeks/<1800 g) on full oral gastric tube feeding for at least 3 consecutive days, eligible to be given a trial of suck and swallow cup feeding, prior to initiation of direct breastfeeding, were randomized to the two feeding intervention groups: paladai cup and Nifty cup. The primary outcome was the time taken from initiation of oral cup feeds to reaching complete gavage-free cup feeds for at least 24 hours. Secondary outcomes were the ease of use of both instruments, the adverse effects during and within 10 minutes after feeding, and anthropometric parameters (head circumference and weight gain).

Results:

The median (IQR) time taken from initiation to complete transition to full cup feeding for at least 24 hours was not significantly different [4(3,7) days in Nifty cup group versus 3(2,6) days in paladai cup group, p = 0.25]. Mean ± SD weight gain from intervention to discharge was also similar in both the groups (16 ± 6 g/kg/day in Nifty cup group versus 17 ± 5 g/kg/day in paladai cup group, p = 0.18). Adverse events did not differ (32.9% in group A versus 27.1% in group B, p = 0.580). Nurses did not find any difference in ease of teaching caregivers [median (IQR) Nifty cup group 4(4,5) versus paladai cup group 4(4,5), p = 0.13].

Conclusion:

The efficacy and adverse event rates were similar between Nifty cup feeding and paladai cup feeding in preterm infants. Both feeding modalities can be used prior to transition to direct breastfeeding in preterm low-birth-weight infants.

Introduction

Breastfeeding is the best mode of infant feeding, but for premature infants, it might not always be possible because of developmental immaturity.^1,2 Consequently, these babies are often transitioned from tube feeding to oral feeding using various devices such as cups, spoons, or bottle, before initiating breastfeeding. Cup feeding is generally preferred in low- and middle-income countries (LMIC's) like India because it does not cause nipple confusion, results in better exposure to smell and taste of the milk, and babies can decide the suction and the quantum of feeds.^3,4 However, the longer feed duration and spillage are often cited as disadvantages.^5,6

Paladai cups have traditionally been used in southern India for this purpose. This is a metal cup made of brass or stainless steel that has a tapered end to introduce feed into the babies’ mouth. This method has been endorsed by the World Health Organization and UNICEF as the preferred feeding method in LMIC's, where infection secondary to bottle feeds is potentially high.^7,8

In order to appropriate the best features of the paladai cup, Neonatal Intuitive Feeding Technology (NIFTY) cup was developed.⁹ The purported advantages include a soft silicone material that could potentially avoiding oral mucosal injuries that are common with metallic paladai cups and ergonomic design that allows controlled milk flow, thereby avoiding spillage and regurgitation.¹⁰ Recent studies have demonstrated the feasibility of Nifty cup use in preterm populations from LMIC’s,^9–14 but the direct comparison with the original paladai cup is lacking. Hence, we compared the efficacy, caregiver acceptance, and adverse event rate of Nifty cup feeding against the commonly used paladai cup in preterm infants. We hypothesized that Nifty cup feeding could aid in a faster transition to full oral feeding in preterm infants, compared with the traditionally used paladai cup (Fig. 2).

Materials and Methods

An open labeled, randomized controlled trial was conducted in a tertiary neonatal intensive care unit in southern India, from January 2021 to June 2022. Approval from the Human Ethics Committee (135/IHEC/August2020 dated 26/09/2020) and the Clinical Trials Registry of India registration (CTRI/2022/02/040035) were obtained. All preterm infants (<34 weeks/<1800 g) on full gavage feeding for at least 3 consecutive days, eligible to be given a trial of suck and swallow cup feeding, prior to initiation of direct breastfeeding, were randomized after informed consent. We excluded neonates with congenital anomalies such as craniofacial malformations, neurological abnormalities such as hypoxic ischemic encephalopathy (HIE) and seizures, significant gastroesophageal reflux (GER), and infants already taking breastfeeds.

As paladai cup feeding was already in use for feeding preterm infants, it was replaced using Nifty cups from August 2020 to December 2020. This was done to ensure that the nursing staff were more accustomed to its use. As per unit protocol, introduction of suck feeds was done only after postmenstrual age of 30 weeks and off oxygen for at least 24 hours. The physiological stability such as frequency of apneas, intermittent desaturations, oxygen requirement, and tone modulation were also taken into consideration before suck feeds introduction. For infants with postmenstrual age ≥ 30 weeks, once off oxygen and hemodynamically stable, and eligible for enteral nutrition, feeds were introduced as per trial intervention (paladai or Nifty). Every feed was attempted with interruptions only for physiological instability and evolving feed intolerance. Routine aspiration of prefeed gastric residue was not followed in our unit in the absence of signs of feed intolerance. Nursing staff with at least 2 years of prior experience were chosen to handle the trial infants, and training about the feeding protocol was done by the investigator along with the prior introduction of the Nifty cup.

Once the treating physician and all nursing staff caring for the infant agreed on the infant’s competence to start suck feeds, the infants were randomly allocated to the two feeding intervention groups—paladai cup and Nifty cup (Fig. 1). Randomization was done through computer-generated random numbers (generated online from randomizer.org accessed on December 31, 2020) by a pediatric social worker who made serially numbered opaque sealed envelopes, which were opened by a member of the treating team after enrollment. The trial infants were stratified as <32 weeks and 32–33 + 6 weeks using permuted even number blocks. Blinding was not attempted due to the nature of the intervention. All neonates underwent intervention according to their allocated group.

FIG. 1.

Paladai cup and Nifty cup.

The primary outcome was the time taken from initiation of oral cup feeds to reaching complete gavage-free cup feeds for at least 24 hours. Secondary outcomes analyzed were the ease of use of both instruments (using an ordinal 5-point scale for ease of holding and usage, comfort of the baby during feed, spillage during feeds, ease of teaching parents, ease of reuse), the adverse effects (apnea, bradycardia, desaturation, choking, injury, regurgitation, extreme events) during and within 10 minutes after feeding, and anthropometric parameters (head circumference and weight gain). Any injury to lip/gums or mucosa by the cup is termed as a significant injury. The ease of use of the cup by the nursing staff was documented within 48 hours, from 48 hours to 7 days, and after 7 days till the end of the study. They can choose from “very unsatisfied” (1) to “very satisfied” (5) on a Likert type scale (Supplementary Data S1) and submit at the end of their shifts, and their anonymity was maintained. Discharge of infants from hospital was done once free of apnea for 5 days and gaining weight >15 g/kg/day for 3 days on gavage-free cup feeding.¹ The postmenstrual age and weight at discharge were also documented as was the duration of hospital stay from initiation of trial intervention.

The antenatal and neonatal demographics recorded were antenatal glucocorticoid exposure, gestation, birthweight, weight categorization, sex, mode of delivery, Apgar score, and need for resuscitation at birth, age at which intervention started, and medication use at that time. As part of routine nursing care, weight was measured daily, except when deemed unsafe by the attending neonatologist. Daily weights were recorded from each participant’s medical file by the investigator. If there were any drastic weight changes, the weight measurement was repeated by the investigator. The weight of the infant was measured daily around the same time in the morning using the same weighing machine with an accuracy of ± 1 g (calibrated at regular intervals). Length and head circumference were measured at birth, on days 7, 14, 21, and 28 of life, by the investigator. Standard, nonstretchable measuring tapes were used to measure the head circumference and length. Length and head circumference were measured to the nearest 0.1 cm. Pulse oximeter with signal extraction technology was used for vitals monitoring.

Assuming that Nifty cup feeding will reduce time to gavage-free cup feeding by a mean of 1 day from 7 ± 2 days in paladai feeds (from prior unit data in infants < 32 weeks), to achieve a power of 80%, alpha error of 0.05, 63 infants were required to be recruited in each group. To account for follow-up losses, we recruited 70 in each group.

Numerical variables were analyzed by student t-test and Mann–Whitney U test for independent samples as applicable. Categorical variables were analyzed by Chi square test or Fisher’s exact test. The p < 0.05 was taken as significant. Analysis was done using IBM SPSS version 23 (SPSS Inc, USA). An intention-to-treat analysis was performed.

Results

Out of 154 eligible infants after exclusions, 70 each were randomized to Nifty and paladai cup feeding. In Nifty cup group, seven infants were switched from Nifty cup to paladai cup, as the treating physician felt they had more feed-related desaturation and apnea. The flow of study infants in the two groups is given in Figure 2.

FIG. 2.

CONSORT diagram depicting flow of the study.

The baseline demographic characteristics of two groups were similar (Table 1). The median (IQR) gestational age was 30.5 (28.6, 32.4) weeks in the Nifty cup group versus 30.2 (28.4, 32.4) weeks in the paladai cup group, p = 0.86. The mean (SD) gestational age and birth weight at which cup feeding was initiated were 32.3 ± 1.4 weeks/1275 (1123, 1616) g in the Nifty cup group versus 32.2 ± 1.4 weeks/1367 (1133, 1647) g in the paladai cup group.

Table 1.

Comparison of Baseline Characteristics

Variable	Nifty cup n = 70	Paladai cup n = 70
Gestational age (weeks)^b	30.5 (28.6, 32.4)	30.2 (28.4, 32.4)
Birth weight (g)^a	1306 ± 433	1353 ± 377
Boys^c	41 (58.6)	38 (54.3)
Mode of delivery—caesarean section^c	62 (88.6)	61 (88.4)
Antenatal steroids received^c	65 (92.9)	62 (88.6)
Need for resuscitation at birth^c	69 (98.6)	69 (98.6)
On caffeine^c	50 (71.4)	46 (65.7)
On antibiotics^c	10 (14.3)	11 (15.7)
On intermittent oxygen^c	6 (8.6)	6 (8.6)
Time to reach full gavage feeds (days)^b	6 (3,10)	6 (3,10)
Postmenstrual age when the intervention was started^a (weeks)	32.3 ± 1.4	32.2 ± 1.4
Weight when the intervention was started^b (grams)	1275 (1123, 1616)	1367 (1133, 1647)

^aMean ± SD.

^bMedian (IQR).

^cn(%).

Analysis (intention-to-treat) of primary outcome (Table 2) showed median (IQR) time taken for transition to complete gavage-free cup feeding for at least 24 hours was similar in both groups [4(3,7) days in Nifty cup group and 3(2,6) days in paladai cup group, p = 0.25]. There was no significant difference in daily weight gain among two groups [Mean difference −1.97, 95% CI (−4.9, 0.98), p = 0.18]. There were no significant differences in the anthropometric parameters at discharge as well.

Table 2.

Comparison of Outcomes among Intervention Groups

Variable	Nifty cupn = 70	Paladai cupn = 70	Meandifference	95% CI formean difference	p value
Primary outcome
Time taken for transition to gavage-free cup feeds for atleast 24 hours (days)^b	4 (3,7)	3 (2,6)	0.963	−0.312, 2.237	0.25
Secondary outcomes
Weight gain (g/kg/day) from starting Nifty cup/ paladai feeding to discharge^a	16.16 ± 5.85	17.38 ± 4.56	−1.97	−4.9, 0.98	0.18
Discharge weight (grams)^a	1376 ± 199	1338 ± 142	−16.43	−114, 81	0.74
Head circumference at discharge (in cm)^a	27.5 ± 1.43	27.3 ± 1.3	0.19	−0.38, 0.78	0.50
Hospital stay from intervention todischarge (days)^b	5 (3, 10)	5.5 (3, 9)	1.17	−0.62, 2.9	0.42
Postmenstrual age at discharge (weeks)^b	33 (32.2, 33,6)	33 (32.2, 34.1)	0.11	−0.42, 0.64	0.82
Adverse events^c	23 (32.9%)	19 (27.1%)			0.58
Desaturation^c	23 (32.9%)	18 (25.7%)			0.46
Bradycardia^c	3 (4.3%)	3 (4.3%)			1
Regurgitation^c	12 (17%)	8 (11.4%)			0.10
Apnea^c	19 (27.1%)	12 (17.1%)			0.22
Other clinical outcomes
Death^c	0 (0)	2 (2.8%)			0.56
Bronchopulmonary dysplasia^c	4 (5.7%)	2 (2.9%)			0.68
Feed intolerance^c	12 (17.1%)	4 (15.7%)			0.60
Necrotizing enterocolitis	—	—			—
Sepsis^c	2 (2.9%)	3 (4.3%)			1

^aMean ± SD.

^bMedian (IQR).

^cn (%).

Table 3.

Ease of Use of the Cups by the Nursing Staff (Using Likert Scale)

Variable	Nifty cup n = 70 median (IQR)	Paladai cup n = 70 median (IQR)	p value
1. Ease of holding and usage
Within 48 hours	3 (2,3)	3 (2,3)	0.07
Week 1	4 (3,4)	4 (3,4)	0.6
After week 1	4 (3,4)	4 (3,4)	0.85
Discharge	4 (4,4)	4 (3,5)	0.45
2. Comfort of the baby during feed
Within 48 hours	2 (2.3,5)	3 (2,3)	0.05
Week 1	3 (3,4)	4 (3,4)	0.92
After week 1	4 (3,4)	4 (3,4)	0.85
Discharge	4 (4,5)	4 (3,4)	0.05
3. Spillage during feeds
Within 48 hours	3 (2,4)	3 (2,3)	0.29
Week 1	4 (3,4.25)	4 (3,4)	092
After week 1	4 (3,4)	4 (3,4)	0.85
Discharge	4 (4,5)	4 (4,5)	0.73
4. Ease of teaching caregivers
Within 48 hours	3 (2,3)	3 (2,3)	0.74
Week 1	5 (4,5)	4 (4,5)	0.3
After week 1	5 (4,5)	5 (4,5)	0.86
Discharge	5 (4,5)	5 (4,5)	0.13
5. Ease of reuse (cleaning and using for subsequent feeds)
Within 48 hours	4 (4,5)	4 (4,5)	0.82
Week 1	5 (4,5)	4 (3,5)	0.11
After week 1	5 (5,5)	5 (5,5)	0.19
Discharge	5 (4,5)	4 (4,5)	0.35

IQR, Interquartile range.

Desaturation and apnea during intervention were the most common adverse events documented, but the overall adverse event rate was not different between intervention groups (Nifty cup group, 32.9%, versus paladai cup group, 27.1%, p = 0.580). There were no significant injuries, choking episodes, or events requiring bag and mask in either of the groups. The clinical outcomes were also not significantly different between the intervention groups. The ease of teaching paladai cup feeding and Nifty cup feeding to the caregivers were not different according to the nurses [median (IQR) Nifty cup group 4(4,5) versus paladai cup group 4(4,5), p = 0.13] (Table 3). None of the other qualitative parameters were different between groups. There was no difference in any outcomes among the two gestational age strata.

Even with per protocol analysis, the time taken for transition to complete cup feeding for at least 24 hours was not statistically different between the groups [4(3,7) days in Nifty cup group (n = 63) and 6(4,10) days in paladai cup group (n = 77), p = 0.48]. There were no differences in secondary outcomes between the groups as well.

Discussion

Contrary to our study hypothesis that Nifty cup feeding could reduce the time to complete gavage-free cup feeds compared to paladai cup, we found no difference in this outcome in our study. This finding was not unexpected as the Nifty cup was modeled on the traditional paladai. The volume of milk that the paladai cup can hold is around 10 mL which is less than the 40 mL of milk that the Nifty cup can. The smaller reservoir in Nifty cup could potentially make it easier to hold with the caregiver’s finger, and one can control the pace of milk flow better. Cup-fed preterm infants generally “lap up” the milk from the snout of the cup, and this could vary between infants depending on their physiological maturity. Therefore, controlling the milk flow based on the caregiver’s observation of this lapping up is crucial for successful cup feeding.

Previous studies using Nifty cup in preterm infants have compared it with a katori spoon or medicine cup. Gujjar N et al.¹⁰ in their RCT comparing Nifty cup with katori spoon did not find any difference in time to complete oral feeds. However, full breastfeeds were attained earlier, and less vomiting was reported in the Nifty cup fed infants. Also, parental and nursing experience was better with Nifty cup compared with katori spoon feeding. This trial was conducted in a center where katori spoon feeding was traditionally used and was undertaken to explore whether cup feeding was a better alternative feeding method. The other clinical trial by McKinney et al.¹¹ compared Nifty cup with a medicine cup for feeding low-birth-weight infants in Africa and reported a better caregiver experience with Nifty cup. This experience was assessed by an interviewer-administered survey whereas we used a Likert scale and compared the scores between both the groups. The medicine cup used in their trial differs from the paladai cup as it does not have a beaked feeding spout, which acts as a small reservoir and correctly directs the milk flow as deemed by the caregiver. Therefore, the results of both of these trials cannot be extrapolated to ours as the control intervention was not paladai cup feeding as used in ours.

The main perceived disadvantage of paladai cup feeding was the small volume of the cup, which precluded direct breast milk expression into the cup, and the metallic material, which could potentially result in sharp edges that might injure the oral mucosa of the infant.¹⁰ In neonatal units accustomed to paladai use, the injury concern is addressed by choosing brass or bronze paladai with blunt edges. Also, the spout beaked tip is placed near the angle of the mouth, and the caregivers generally avoid forceful or deep introduction into the infant’s mouth to avoid injury. This complication was monitored in our trial also, and we did not encounter any significant injury related to paladai use during the trial period. This could also be the result of the greater years of experience of our nursing staff involved in the trial. Frequent transfers of small volumes of milk from the expression container to the paladai could result in contamination, but the sepsis rates from trial onset were comparable between the groups.

In our trial, seven infants in the Nifty cup group were switched over to paladai cup as per the advice of the treating physician. The reasons were not analyzed but could be related to the caregiver’s rich experience in use of paladai cups over the relatively new Nifty cups. However, in keeping with the study principles of RCT’s, the intention-to-treat analysis was performed. But this observation questions the results of the questionnaire that assessed the ease of use of the study interventions. To alleviate respondent bias, we introduced the nifty cup in our unit for feeding preterm infants 5 months before study onset to make the nursing staff conversant with its use. Also, the ease-of-use responses were evaluated multiple times from trial initiation to study whether nursing perception changed over time once the staff became more accustomed to using the study intervention. In our study, the median scores did not change over time and the marginal, but significant difference in ease of teaching parents observed in the paladai cup group could be biased.

To the best of our knowledge, this is the first RCT that has compared two nearly similar cups for feeding preterm infants. The strengths of our study include our study design, which, in addition to being an RCT, also has provisions to measure the nursing experience. The results of our study are also applicable to high-income settings in addition to low- and middle-income countries, as our study population included more infants < 32 weeks. In addition to full cup feeding, the growth parameters, adverse event rates, and ease of use were also measured unlike most previous studies.¹⁵

The major drawback of our study was that the intervention could not be blinded. So, protocol deviations were observed in the Nifty cup group. Also, we did not measure the effect on initiation of breastfeeding or complete breastfeeding rates, as the trial concluded when the infant was discharged form hospital and breast feeding was not mandatory at discharge in our unit. Though the spillage could not be quantified, the nursing staff perceived it as same between both the groups. In our unit, transition to cup feeding was done by the nursing staff, and mothers were taught about the intervention only after the nursing staff was confident about the infant’s feeding competence. We did not evaluate the mother’s experience with the intervention, which would have been useful, as it would have provided a better real-world experience where family-integrated preterm care is gaining more acceptance.

The free availability of Nifty cups in less resourced settings is encouraging as it offers an ergonomically designed cup incorporating all the advantages of the traditional paladai cup at a very affordable cost. It would be desirable to have the Nifty cup in more sizes from small to large, to cater to the needs of the nursing staff who are more experienced with using small cups. Also, a crossover study design, evaluation of maternal experience and long-term breast-feeding rates would be required in the future.

In conclusion, both Nifty and paladai cup were similar in efficacy and safety for feeding preterm infants. The nurses could be biased due to the expertise and practice of using the paladai cup over the past few years, and hence further studies are required once there is more experience with Nifty cup use. At this time, both feeding modalities can be used prior to transition to direct breastfeeding in preterm low-birth-weight infants.

Availability of Data and Material

The data that support the findings of this study are available from the corresponding author, G.S., upon reasonable request.

Authors' Contributions

Conception/design of the research, G.S. and U.D.; Acquisition, analysis, or interpretation of the data, P.D., U.P., G.S., and U.D.; Initial Draft of the article, P.D.; Critical revision of the article, G.S. and U.D.; and Supervision, G.S. and U.D. All authors read and approved the final article.

Footnotes

Author Disclosure Statement

The authors declare no conflict of interest.

Funding Information

No funding was received for this article.

Supplementary Material

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