Authors’ Response to the Letter to the Editor Regarding “ Impact of Oromotor Stimulation on Transition from Gavage to Full Oral Feeding in Preterm Neonates: A Randomized Controlled Trial ”

Absence of Objective Measures of Oromotor Function

Kaur and Goyal correctly observe that our study did not incorporate objective measures of oromotor function, such as sucking coordination, oral motor control, or feeding efficiency indices. We acknowledge this as a limitation. However, it is important to note that the primary objective of our trial was to evaluate the clinical impact of PIOMI on the timeline of feeding transition, using outcomes that are directly meaningful in a resource-limited neonatal intensive care units (NICU) setting—namely, time to full katori spoon feeding and time to full breastfeeding. These endpoints are operationally relevant and have been used consistently across comparable trials in the literature.^3–5

Objective oromotor assessments—such as the Neonatal Oral-Motor Assessment Scale or instrumented sucking analysis—require specialized equipment and trained personnel that were not uniformly available at our rural tertiary care center. Requiring such measures as a prerequisite would have significantly constrained enrollment and undermined the external validity of this study within the very settings where PIOMI is most needed. We agree that future trials—particularly those conducted in better-resourced environments—should incorporate objective oromotor assessments to elucidate the mechanistic pathway by which PIOMI facilitates earlier feeding transition.

Baseline Oral Motor Readiness

The concern regarding baseline oral motor readiness is well taken. As detailed in our methodology, randomization was performed using computer-generated random numbers, and the two groups were well-matched on all available baseline demographic and clinical parameters—including gestational age, birth weight, sex, mode of delivery, antenatal care visits, and type of milk received (Table 1 of the original article). The mean gestational age was 30.45 ± 1.25 weeks in the intervention group and 30.32 ± 1.16 weeks in the control group (p > 0.05), and birth weight was similarly comparable (p > 0.05).

Formal pre-intervention feeding readiness assessments—such as the Oral Feeding Readiness Assessment or Preterm Infant Breastfeeding Behavior Scale—were not performed. We concede that reporting baseline oral motor readiness scores would have strengthened the internal validity of the study. However, all enrolled neonates were hemodynamically stable and about to begin orogastric feeding, which itself functions as a standardized clinical threshold for feeding readiness in our setting. The consistent treatment effect observed across all four gestational age strata (p-interaction = 0.998) further supports baseline comparability between groups.

Confounding Variables Influencing Feeding Milestone Attainment

The commentators rightly identify that feeding progression in preterm infants is multifactorial, encompassing gestational age, birth weight, respiratory stability, behavioral state, and feeding readiness. In our study, neonates who were hemodynamically unstable, on oxygen support, or diagnosed with major morbidities such as necrotizing enterocolitis, intraventricular hemorrhage, or hypoxic-ischemic encephalopathy were explicitly excluded. This exclusion criterion effectively standardized the enrolled population with respect to respiratory and physiological stability—key confounders of feeding progression.

Furthermore, stratified randomization by gestational age into four categories (28–29, 29–30, 30–31, and 31–32 weeks) was employed specifically to control for this primary biological confounder. The lack of a significant treatment-by-gestational-age interaction (p-interaction = 0.998) confirms that the benefit of PIOMI was homogeneous across gestational age subgroups. We acknowledge, however, that residual confounding from unmeasured behavioral state variables or caregiver involvement variability cannot be fully excluded. Multivariable regression adjustment for additional covariates is a methodological refinement we recommend for future studies.

Length of Hospital Stay as an Outcome

We appreciate this critique and fully acknowledge that length of hospital stay (LOS) is a clinically and economically significant endpoint, particularly in the resource-constrained Indian health care context that motivated this study. LOS was not pre-specified as a primary or secondary outcome in the original trial protocol, and we chose not to report it post-hoc in order to maintain methodological integrity and avoid inflating the number of outcome comparisons. Discharge decisions in our NICU are also governed by a composite of clinical criteria beyond oral feeding attainment—including weight gain trajectory, thermoregulation, and parental readiness—that could introduce heterogeneity in LOS estimates.

Nonetheless, we note that the statistically significant reductions in time to full katori spoon feeding (by 6.89 days) and full breastfeeding (by 5.71 days) observed in the PIOMI group are strong proxies for earlier discharge eligibility. These findings are consistent with previously published studies demonstrating reduced LOS with PIOMI-like oromotor interventions.^3–6 We strongly recommend that future prospective trials register LOS as a pre-specified secondary outcome.

In conclusion, we are grateful to Kaur and Goyal for their careful reading and scholarly engagement with our work. Their suggestions—integration of objective oromotor assessment tools, formal baseline feeding readiness scoring, multivariable confounding analysis, and prospective LOS reporting—constitute a valuable methodological roadmap for the next generation of PIOMI trials. We believe that this structured oromotor intervention holds significant promise for improving feeding outcomes in preterm neonates, particularly in low-resource settings, and we look forward to continued investigation in this important area.