Effect of Premature Infant Oral Motor Intervention for early Transition to Oral Feeding in Preterm Infants: A Randomized Controlled Trial
Phase 3
- Conditions
- Health Condition 1: P073- Preterm [premature] newborn [other]Health Condition 2: P073- Preterm [premature] newborn [other]
- Registration Number
- CTRI/2019/06/019853
- Lead Sponsor
- Dr RML Hospital New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All Preterm babies born between 28+0 â?? 32+6 weeks of gestation (by best gestational age estimate) and admitted to NICU who were hemodynamically stable, reached full gavage feeding and in transition from gavage to spoon feeds, receiving non-nutritive sucking and KMC as routine care.
Exclusion Criteria
Babies having respiratory distress, on continuous positive airway pressure /Ventilator, medical conditions like IVH grade 2 or beyond, NEC stage 2 or beyond, PVL, BPD and having chromosomal anomalies or congenital malformations
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time taken to transition from gavage feeds to full spoon feedsTimepoint: every 3rd day till full spoon feed is achieved
- Secondary Outcome Measures
Name Time Method Breastfeeding rates at discharge and at 1 month after dischargeTimepoint: Every weekly till discharge and then every two weekly till 1 month after discharge;Episodes of bradycardia or desaturation (during or immediately after feeding) <br/ ><br>Timepoint: 2 to 3 times per day in the first week after initiation of intervention and subsequently, every 48 hours till discharge or till complete breast feeding was achieved;Late onset sepsis rates <br/ ><br>Timepoint: As and when the baby is symptomatic;Weight gain <br/ ><br>Timepoint: weekly till the attainment of full breastfeeding.