Method of Feeding of Very Small Newborns
Not Applicable
- Conditions
- Health Condition 1: P059- Newborn affected by slow intrauterine growth, unspecified
- Registration Number
- CTRI/2020/03/023683
- Lead Sponsor
- Banaras Hindu University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 89
Inclusion Criteria
1. Birth weight between 1000-1499 g
Exclusion Criteria
1.Hemodynamic instability
2.Delivery room resuscitation >1 minute accompanied by neonatal encephalopathy
3.Inability to feed orally due to severe respiratory distress or sickness
4.Reversal of end-diastolic flow on maternal ultrasound
5.Major congenital malformation
6.Failure to obtain informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of extrauterine growth restriction defined as growth parameters (weight, length, head circumference) for postmenstrual age below or equal to 10th centile (Z score below -1.28) as per Intergrowth 21st referenceTimepoint: Hospital discharge
- Secondary Outcome Measures
Name Time Method 1. Late onset sepsis, defined as per European Medicines Agency (modified) <br/ ><br>2. Feeding intolerance <br/ ><br>3. Necrotizing enterocolitis defined as Bells stage 2 or 3 <br/ ><br>4. Time to regain birth weight <br/ ><br>5. Time to achieve full volume feeding <br/ ><br>6. Mortality before hospital discharge <br/ ><br>7. Duration of hospital stay <br/ ><br>8. Rate of exclusive breastfeeding at hospital discharge <br/ ><br>9. Physical growth-weight, length and head circumference at hospital discharge, 3 months, 6 months and 1 year <br/ ><br>Timepoint: Hospital discharge for outcomes 1 to 8 <br/ ><br>One year for outcome 9