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

Lady Hardinge Medical College

Status: Unknown

Conditions: Very Low Birth Weight Baby

Treatments: Other: developmentally supportive care

Study type: Interventional

Funder types: Other

Identifiers

NCT02817022

Developmental supportive care

Details and patient eligibility

About

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 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 1 day to 37 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

developmentally supportive care

Other group

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

Treatment:

Other: developmentally supportive care