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

Very Low Birth Weight Baby Clinical Trial

— DSC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02817022
• Other study ID #: Developmental supportive care
• Status: Recruiting
• Phase: N/A
• First received: April 29, 2016
• Last updated: June 24, 2016
• Start date: January 2016
• Est. completion date: June 2017

Study information

• Verified date: June 2016
• Source: Lady Hardinge Medical College
• Contact: VIKRAM DATTA, MD,DNB
• Phone: 91-1123344151
• Email: drvikramdatta[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 37 Weeks

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Birth Weight
• Very Low Birth Weight Baby

Intervention

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

Locations

Country	Name	City	State
India	Lady Hardinge Medical College,New Delhi	Delhi
India	Lady Hardinge Medical College	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Lady Hardinge Medical College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of apneic episodes during hospital stay	will be measured as per standard definition of neonatal apnea and expressed as numbers.	18 months	No
Other	IVH Grade 2 or more	will be measured using bedside cranial sonogram and classified using Volpe's classification.	18 months	No
Other	BPD	Presence or absence will be noted and mentioned as yes or no.	18 months	No
Other	NEC Stage 2 or more	Will be staged using Bells staging .	18 months	No
Other	ROP (any stage)	Will be graded using standard classification .	18 months	No
Primary	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	No
Secondary	Time to achieve full feeds @150ml/kg	Time to achieve full feed @150 ml/kg/day will be measured in days.	18 months	No
Secondary	Length of hospital stay	will be measured in days	18 months	No