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

Overview

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).

Full Title of Study: “Evaluation of the Effect of Application of Developmentally Supportive Care on Neurobehavioral Outcome of Preterm Very Low Birth Weight Neonates”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2017

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.

Interventions

  • Other: developmentally supportive care
    • 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

Arms, Groups and Cohorts

  • Other: 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 1 Day

Maximum Age: 37 Weeks

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Lady Hardinge Medical College
  • Provider of Information About this Clinical Study
    • Principal Investigator: DR. VIKRAM DATTA, professor – Lady Hardinge Medical College
  • Overall Contact(s)
    • VIKRAM DATTA, MD,DNB, 91-1123344151, drvikramdatta@gmail.com

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