Clinical trial NCT02817022: Developmentally Supportive Care on Neurobehavioral Outcome of Preterm Very Low Birth Weight Neonates
Official title: Evaluation of the Effect of Application of Developmentally Supportive Care on Neurobehavioral Outcome of Preterm Very Low Birth Weight Neonates
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Very Low Birth Weight Baby
Keywords: Developmentally Supportive Care
Lead sponsor: Lady Hardinge Medical College
Sponsor class: OTHER_GOV
First posted: 2016-06-29
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Neurobehavioral outcome Of the Preterm Very low birth weight babies
timeFrame: 18 months
Secondary outcomes:
measure: Time to achieve full feeds @150ml/kg
timeFrame: 18 months
measure: Length of hospital stay
timeFrame: 18 months
Other outcomes:
measure: Number of apneic episodes during hospital stay
timeFrame: 18 months
measure: IVH Grade 2 or more
timeFrame: 18 months
measure: BPD
timeFrame: 18 months
measure: NEC Stage 2 or more
timeFrame: 18 months
measure: ROP (any stage)
timeFrame: 18 months
Locations:
city: New Delhi
country: India
facility: Lady Hardinge Medical College
state: Delhi
city: Delhi
country: India
facility: Lady Hardinge Medical College,New Delhi
Study officials:
References: