Study of effect of early kangaroo mother care on babies with birth weight less than 1500grams
- Conditions
- Premature very low birth weight infant
- Registration Number
- CTRI/2021/10/037264
- Lead Sponsor
- NA
- Brief Summary
Kangaroo mother care (KMC) is a very effective intervention for improving outcomes among preterm low birth weight neonates. KMC compared to standard of care has reduced neonatal mortality in Low Birth Weight (LBW) neonates by 36%. Early Skin to Skin Contact (SSC) among term neonates has shown beneficial effects on breastfeeding one to four months post-birth, blood glucose, infant crying, and infant temperature stability.
However, studies regarding KMC given to very preterm neonates especially neonates weighing ≤1500 grams, initiated early during NICU stay are limited. This period is very fragile especially when the neonates are on respiratory support and are prone to hemodynamic instability and as result vulnerable to higher morbidities and mortality.
We aim to conduct a randomized control trial to find out the outcome in moderately sick neonates weighing ≤1500 grams with early initiation of KMC vs. those with no early KMC (standard care).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 126
Preterm babies weighing ≤ 1500 grams Age: within 7 days of life Mother or any other caregiver available and willing to provide KMC Babies with stable cardio-respiratory parameters i.e. requirement of one inotrope, ≤2 apnea episodes in 24 hours, babies on respiratory support (MAP < 8 cms and FIO2< 60%) both invasive and non-invasive ventilation.
- 1.Neonates with major congenital anomalies and syndromic babies.
- 2.Neonates on high-frequency ventilation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To study the effect of early KMC in babies weighing ≤ 1500 grams on hospital stay compared with standard care. AT 40 WEEKS OF GESTATIONAL AGE | AT 18 MONTHS OF AGE
- Secondary Outcome Measures
Name Time Method 1. To study the incidence of sepsis, necrotizing enterocolitis, bronchopulmonary dysplasia, intraventricular hemorrhage, apnoea, and feed intolerance. 2. To study the growth at 40 weeks corrected age in both the groups for extra-uterine growth retardation (EUGR).
Trial Locations
- Locations (1)
KEM HOSPITAL PUNE
🇮🇳Pune, MAHARASHTRA, India
KEM HOSPITAL PUNE🇮🇳Pune, MAHARASHTRA, IndiaDR SANDEEP KADAMPrincipal investigator9850609628drsandeepkadam@gmail.com