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

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

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).

Study Overview

• Status: Unknown
• Conditions: Very Low Birth Weight Baby
• Intervention / Treatment: Other: developmentally supportive care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi, India
    • Recruiting
    • Lady Hardinge Medical College,New Delhi
    • Contact: Vikram Datta, MD; Phone Number: 919350801230; Email: vikramdatta71@yahoo.com
    • Principal Investigator: Vikram Datta, MD
  • Delhi
    • New Delhi, Delhi, India, 110001
      • Recruiting
      • Lady Hardinge Medical College
      • Contact: Vikram Datta, MD,DNB; Phone Number: +919899114104; Email: drvikramdatta@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurobehavioral outcome Of the Preterm Very low birth weight babies	Neurobehavioural outcome will be measured by NAPI at 37 weeks of corrected gestational age.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to achieve full feeds @150ml/kg	Time to achieve full feed @150 ml/kg/day will be measured in days.	18 months
Length of hospital stay	will be measured in days	18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of apneic episodes during hospital stay	will be measured as per standard definition of neonatal apnea and expressed as numbers.	18 months
IVH Grade 2 or more	will be measured using bedside cranial sonogram and classified using Volpe's classification.	18 months
BPD	Presence or absence will be noted and mentioned as yes or no.	18 months
NEC Stage 2 or more	Will be staged using Bells staging .	18 months
ROP (any stage)	Will be graded using standard classification .	18 months

Collaborators and Investigators

• Sponsor: Lady Hardinge Medical College

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: April 29, 2016
• First Submitted That Met QC Criteria: June 24, 2016
• First Posted (Estimate): June 29, 2016

Study Record Updates

• Last Update Posted (Estimate): June 29, 2016
• Last Update Submitted That Met QC Criteria: June 24, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Developmentally Supportive Care
• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: Developmental supportive care

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED