1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [yaavan13@gmail.com].
   


6. For how long will this data be available start date provided 01-09-2025 and end date provided 01-09-2027?
   Response - Beginning 9 months and ending 36 months following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - nil

Successful enteral feeding is one of the important discharge criterion for preterm infants. Mother and attenders have to demonstrate a successful and confident training in giving paladai feeds to babies who were on prolonged OG feeds. In routine practice, we use postmenstrual age and weight to initiate paladai feeds. With improving quality of perinatal and neonatal care; infants are achieving hemodynamic stability earlier and they are made to stay in NICU till it achieves particular PMA and weight to initiate feeds. This leads to prolonged hospital stay in turn increasing expenditure and prolongation of separation between mother and her baby. Studies have been conducted which show that infants exhibit hunger cues, feeding cues and stress cues. Initiating and escalating feeds based on these cues help to initiate feeds earlier leading to lesser hospital stay and lesser separation between mother and her baby. Training mother about these cues and feeding the baby based on these cues also help in improved bonding between the mother-baby dyad. So, we have taken up this study to look at the outcomes of the babies fed on cues versus babies fed on routine scheduled based [based on post menstrual age and weight] feed. This study can provide useful information on practical application of cue based feeding in NICUs.

All hemodynamically stable infants born less than or equal to 32 weeks of gestation; once reaching full enteral feeds and off iv fluids; informed parental consent was obtained and then, are randomised into cue based feeding group and scheduled feeding group through computer generated randomization and  allocation concealment was done through sequentially numbered opaque envelopes. Envelopes are opened prior to start of trial of paladai feeds. Once, recruited into cue based feeding group; infant is assessed for feeding cues, hunger cues and initiated on paladai feeds on physician’s order. A written Infant Driven Feeding protocol is made and all people involved in caregiving of the child; nursing staff, parents and attenders are taught feeding cues, hunger cues and stress cues. Once the infant completes the first milestone i.e taking 75% of the feed volume within 30 mins without significant apnea, bradycardia or desaturation episodes; with appropriate weight gain (10 to 15 g/kg/24 h); he/she is advanced to two oral feedings per shift. After successfully completing  the two oral feeds per shift milestone, the mother is asked to feed the infant under supervision. Further increment of feeds depends on mother’s and bedside nurses’s assessment of feeding of the baby. Infant is advanced to ad libitum oral feeding subsequently. Weight gain is recorded every day. The nasogastric tube is removed once the infant had appropriate weight gain for 48 hrs without supplementation by nasogastric tube.

Every feeding attempt is monitored for stress cues, and if present; the attempt would be halted. The paladai feeding attempt is continued only as long as the infant showed signs of stability such as smooth and regular respirations, appropriate postural control, focused and clear alertness, good coordination of sucking, swallowing and breathing and optimal color. 

If recruited into scheduled feeding group; paladai feeds are initiated only when the baby reached 32 weeks PMA or 1000g weight. Feeds are advanced according to the standard scheduled feeding protocol. Nasogastric tube is removed when the infant is on full paladai feeds for 48 hours with appropriate weight gain. 

Time from onset to receiving full paladai feeds, no. of days of hospital stay, average weight gain in both groups is monitored. To achieve a median duration of 1 week decrease in reaching full paladai feeds in IDF group compared to scheduled group with an alfa error of 5% and power of 80%; a sample of 63 was required in reach group. 

Descriptive statistics will be used to describe baseline variables. Categorical outcome variables will be compared by chi-square or Fisher’s exact test, normally distributed continuous variables by student’s t-test, continuous variables with skewed distribution by Mann- whitney U-test.