Effect of Mother newborn Dyad NICU care as compared to conventional NICU in preterm or very low birth weight neonates requiring NICU care in a Level 3 NICU setting on head growth velocity trajectory- randomized control trial
Phase 3
- Conditions
- Health Condition 1: P073- Preterm [premature] newborn [other]
- Registration Number
- CTRI/2023/02/049648
- Lead Sponsor
- AIIMS JODHPUR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All inborn neonates,less than 32 weeks gestation or less than 1500 grams birth weight requirirng NICU admission at birth.
Exclusion Criteria
1. Babies known to be requiring surgical intervention at the time of NICU admission.
2. Babies with major congenital malformations.
3. Babies whose mother is sick and unlikely to be providing newborn care in first 72 hours after birth in NICU.
4. Non availability of NICU bed.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Head circumference in cmTimepoint: 39± 2 weeks of post mensural age in
- Secondary Outcome Measures
Name Time Method 1)Neonatal mortality: Proportion of babies expired till discharge. <br/ ><br>2)Neonatal morbidities: Proportion of babies developing sepsis, Number of sepsis episodes in babies; Proportion of babies developing Stage 2b or higher NEC; Proportion of babies developing BPD; Proportion of babies having grade 2/ 3 IVH; Proportion of babies developing Retinopathy of prematurity. <br/ ><br>3)Duration of hospital stay in terms of calendar days. <br/ ><br>4)Duration of mechanical ventilation in terms of calendar days. <br/ ><br>5)Time required to regain birth weight in terms of calendar days <br/ ><br>Time to achieve full feeds in terms of Day of life. <br/ ><br>Timepoint: Till discharge