Clinical Trial: Developmentally Supportive Care on Neurobehavioral Outcome of Preterm Very Low Birth Weight Neonates

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Evaluation of the Effect of Application of Developmentally Supportive Care on Neurobehavioral Outcome of Preterm Very Low Birth Weight Neonates

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 Summary:

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.


Sponsor: Lady Hardinge Medical College

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time to achieve full feeds @150ml/kg [ Time Frame: 18 months ]
    Time to achieve full feed @150 ml/kg/day will be measured in days.
  • Length of hospital stay [ Time Frame: 18 months ]
    will be measured in days


Original Secondary Outcome: Same as current

Information By: Lady Hardinge Medical College

Dates:
Date Received: April 29, 2016
Date Started: January 2016
Date Completion: June 2017
Last Updated: June 24, 2016
Last Verified: June 2016