Developmentally Supportive Care on Neurobehavioral Outcome of Preterm Very Low Birth Weight Neonates
- Conditions
- Very Low Birth Weight Baby
- Interventions
- Other: developmentally supportive care
- Registration Number
- NCT02817022
- Lead Sponsor
- Lady Hardinge Medical College
- Brief Summary
Enrolled neonates will be provided routine supportive care as per existing neonatal intensive care unit (NICU)protocols. This will be carried out in the initial 6 months (0-180 days) of study commencement. This group will serve as control group (group A). During subsequent 6 months (181-360 days) of the study period, enrolled neonates fulfilling the inclusion criteria will be provided routine supportive care and the components of developmentally supportive care (DSC).
- Detailed Description
Enrolled neonates will be provided routine supportive care as per existing NICU protocols. This will be carried out in the initial 6 months (0-180 days) of study commencement. This group will serve as control group (group A). During subsequent 6 months (181-360 days) of the study period, enrolled neonates fulfilling the inclusion criteria will be provided routine supportive care and the components of developmentally supportive care (DSC). DSC components will be strictly emphasized on protected sleep, pain and stress assessment and management, activities of daily living (positioning, feeding and skin care), the healing environment. This group will be designated as group B. Both the groups will receive appropriate management for their morbidities as per existing NICU protocols. Both the groups will be followed up till 37 weeks of gestation where in their neurobehavioral assessment will be performed using Neurobehavioural assessment of preterm infants score.
In both the groups all the baseline data regarding antenatal factors will be recorded in a predesigned proforma such as age, gravid, Gestational age, Chorioamnionitis, Prenatal steroids, Multiple pregnancy, maternal comorbidities (preeclampsia, gestational diabetes mellitus), mode of delivery etc.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- All stable preterm very low birth weight babies not on invasive mechanical ventilation
- Hemodynamically stable
- Parental consent
- Babies with major congenital anomalies
- Asphyxia (Apgar score <3 at 5mins).
- Acute bilirubin encephalopathy
- Hypoglycemia at enrollment
- Clinical Chorioamnionitis(fever > 100.4 ◦ f , uterine fundal tenderness, maternal tachycardia (>100/min), fetal tachycardia (>160/min) and purulent or foul amniotic fluid )
- History of birth trauma
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description developmentally supportive care developmentally supportive care enrolled neonates will be provided routine supportive care as per existing NICU protocols. This will be carried out in the initial 6 months (0-180 days) of study commencement. This group will serve as control group (group A). During subsequent 6 months (181-360 days) of the study period, enrolled neonates fulfilling the inclusion criteria will be provided routine supportive care and the components of developmentally supportive care(DSC). DSC components will be strictly emphasized on protected sleep, pain and stress assessment and management, activities of daily living (positioning, feeding and skin care), the healing environment. This group will be designated as group B
- Primary Outcome Measures
Name Time Method Neurobehavioral outcome Of the Preterm Very low birth weight babies 18 months Neurobehavioural outcome will be measured by NAPI at 37 weeks of corrected gestational age.
- Secondary Outcome Measures
Name Time Method Time to achieve full feeds @150ml/kg 18 months Time to achieve full feed @150 ml/kg/day will be measured in days.
Length of hospital stay 18 months will be measured in days
Trial Locations
- Locations (2)
Lady Hardinge Medical College,New Delhi
🇮🇳Delhi, India
Lady Hardinge Medical College
🇮🇳New Delhi, Delhi, India