Evaluation of the Effect of Application of Developmentally Supportive Care on Neurobehavioral Outcome of Preterm Very Low Birth Weight Neonates
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Very Low Birth Weight Baby
- Sponsor
- Lady Hardinge Medical College
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Neurobehavioral outcome Of the Preterm Very low birth weight babies
- Last Updated
- 9 years ago
Overview
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.
Investigators
DR. VIKRAM DATTA
professor
Lady Hardinge Medical College
Eligibility Criteria
Inclusion Criteria
- •All stable preterm very low birth weight babies not on invasive mechanical ventilation
- •Hemodynamically stable
- •Parental consent
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Neurobehavioral outcome Of the Preterm Very low birth weight babies
Time Frame: 18 months
Neurobehavioural outcome will be measured by NAPI at 37 weeks of corrected gestational age.
Secondary Outcomes
- Time to achieve full feeds @150ml/kg(18 months)
- Length of hospital stay(18 months)