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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Very Low Birth Weight Baby

Intervention / Treatment
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* Other: developmentally supportive care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 37 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: developmentally supportive care<br>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<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Developmentally Supportive Care