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

Primary Purpose

Very Low Birth Weight Baby

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
developmentally supportive care
Sponsored by
Lady Hardinge Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Very Low Birth Weight Baby focused on measuring Developmentally Supportive Care

Eligibility Criteria

1 Day - 37 Weeks (Child)All SexesDoes not accept 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

Sites / Locations

  • Lady Hardinge Medical CollegeRecruiting
  • Lady Hardinge Medical College,New DelhiRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

developmentally supportive care

Arm 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

Outcomes

Primary Outcome Measures

Neurobehavioral outcome Of the Preterm Very low birth weight babies
Neurobehavioural outcome will be measured by NAPI at 37 weeks of corrected gestational age.

Secondary Outcome Measures

Time to achieve full feeds @150ml/kg
Time to achieve full feed @150 ml/kg/day will be measured in days.
Length of hospital stay
will be measured in days

Full Information

First Posted
April 29, 2016
Last Updated
June 24, 2016
Sponsor
Lady Hardinge Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT02817022
Brief Title
Developmentally Supportive Care on Neurobehavioral Outcome of Preterm Very Low Birth Weight Neonates
Acronym
DSC
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

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lady Hardinge Medical College

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Very Low Birth Weight Baby
Keywords
Developmentally Supportive Care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
developmentally supportive care
Arm Type
Other
Arm 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
Intervention Type
Other
Intervention Name(s)
developmentally supportive care
Intervention Description
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
Primary Outcome Measure Information:
Title
Neurobehavioral outcome Of the Preterm Very low birth weight babies
Description
Neurobehavioural outcome will be measured by NAPI at 37 weeks of corrected gestational age.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Time to achieve full feeds @150ml/kg
Description
Time to achieve full feed @150 ml/kg/day will be measured in days.
Time Frame
18 months
Title
Length of hospital stay
Description
will be measured in days
Time Frame
18 months
Other Pre-specified Outcome Measures:
Title
Number of apneic episodes during hospital stay
Description
will be measured as per standard definition of neonatal apnea and expressed as numbers.
Time Frame
18 months
Title
IVH Grade 2 or more
Description
will be measured using bedside cranial sonogram and classified using Volpe's classification.
Time Frame
18 months
Title
BPD
Description
Presence or absence will be noted and mentioned as yes or no.
Time Frame
18 months
Title
NEC Stage 2 or more
Description
Will be staged using Bells staging .
Time Frame
18 months
Title
ROP (any stage)
Description
Will be graded using standard classification .
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
VIKRAM DATTA, MD,DNB
Phone
91-1123344151
Ext
329
Email
drvikramdatta@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
ARVIND SAILI, MD,FRCPCH
Phone
91-1123344151
Ext
335
Email
sailiarvind@gmail.com
Facility Information:
Facility Name
Lady Hardinge Medical College
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vikram Datta, MD,DNB
Phone
+919899114104
Email
drvikramdatta@gmail.com
Facility Name
Lady Hardinge Medical College,New Delhi
City
Delhi
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vikram Datta, MD
Phone
919350801230
Email
vikramdatta71@yahoo.com
First Name & Middle Initial & Last Name & Degree
Vikram Datta, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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