Nifty cup versus katori-spoon feeding in preterm infants – Study protocol of a randomized controlled trial

Preterm neonates need an alternative method of feeding before breastfeeding. : To compare the Nifty cup with Katori-spoon feeding in preterm neonates on full gavage feeds and deemed fit for oral feeding.This open-label, parallel, randomized controlled trial will be done at the step-down unit of a tertiary care center in Northern India. We will include preterm neonates (< 34 weeks gestation) on gavage feeds. Our primary outcome will be the time taken to achieve full oral feeds (defined as 150 mL/kg/day) and the duration of the feeding transition. The secondary outcomes will be time to attain full breastfeeds, time spent during the feeding sessions, spillage of feeds, adverse events (including mortality), anthropometry (weight, length, occipitofrontal circumference) at discharge, and duration of hospitalization.We will also take the opinion of mothers/caregivers and nurses on Nifty cup use by the use of an indigenously designed questionnaire. We will need 94 participants to detect a significant difference of 3 days in transition duration with 5% α error and 80% power. To account for non-compliance/crossover, we will enroll 106 participants (53 in each group).We will do intention to treat analysis. All data will be analyzed using SPSS version 23 statistical software for Windows. We will do a regression analysis to determine if the intervention is an independent predictor of time to full oral feeds after adjusting for pre-specified variables like gestational age, birth weight, and PMA at enrolment.The study will provide evidence on the best feeding method for feeding preterm neonates. This evidence will guide nurses/health care professionals in deciding the feeding method for preterm infants.