NCT02817022

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

June 29, 2016

Status Verified

June 1, 2016

Enrollment Period

1.4 years

First QC Date

April 29, 2016

Last Update Submit

June 24, 2016

Conditions

Very Low Birth Weight Baby

Keywords

Developmentally Supportive Care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Time to achieve full feeds @150ml/kg

    18 months

  • Length of hospital stay

    18 months

Other Outcomes (5)

  • Number of apneic episodes during hospital stay

    18 months

  • IVH Grade 2 or more

    18 months

  • BPD

    18 months

  • +2 more other outcomes

Study Arms (1)

developmentally supportive care

OTHER

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

Interventions

developmentally supportive careOTHER

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

developmentally supportive care

Eligibility Criteria

Age1 Day - 37 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All stable preterm very low birth weight babies not on invasive mechanical ventilation
  • Hemodynamically stable
  • Parental consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lady Hardinge Medical College

New Delhi, National Capital Territory of Delhi, 110001, India

RECRUITING

Lady Hardinge Medical College,New Delhi

Delhi, India

RECRUITING

Central Study Contacts

VIKRAM DATTA, MD,DNB

CONTACT

91-1123344151drvikramdatta@gmail.com

ARVIND SAILI, MD,FRCPCH

CONTACT

91-1123344151sailiarvind@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

April 29, 2016

First Posted

June 29, 2016

Study Start

January 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

June 29, 2016

Record last verified: 2016-06

Locations

IN(2)