Operations Research to Improve Newborn Health

Not Applicable

Completed

• Conditions: Pregnancy Complications

• Registration Number: NCT00198887
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Brief Summary

This study is designed to look at how operations are carried out in relation to improving the health and survival of newborn babies in India.

Detailed Description

The proposed study aims to evaluate the impact of a basic package of obstetric and neonatal care practices implemented by CARE-India as part of their ten-year, two-phase Integrated Nutrition and Health Program (INHP). Building on the lessons learned from the Integrated Nutrition and Health Project I (INHP I) in seven Indian states during 1996-2001, CARE-India has designed INHP II, which focuses on six technical interventions. CARE-India aims to implement this program in 100,000 villages across eight states of India by the year 2006. One of the technical interventions is a focused package of newborn care to be implemented at the community level to improve the health and survival of the newborns, including improvements in care-seeking for maternal and newborn conditions. The services and behaviors promoted include:

1. antenatal care,

2. iron-folate supplementation,

3. tetanus toxoid vaccination,

4. maternal nutrition and rest,

5. birth planning,

6. essential newborn care,

7. immediate and exclusive breastfeeding,

8. prevention of hypothermia,

9. aseptic cord care, and

10. identification and referral of cases with danger signs for both pregnancy/delivery complications and newborn conditions.

The services are provided by first-line community-based health workers.

CARE-India invited Johns Hopkins Bloomberg School of Public Health (JHBSPH) to help evaluate their newborn program in an operations research mode. JHBSPH's role is limited to assisting CARE with the design and evaluation of newborn intervention.

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Study Completion: 2006-10
• Status Verified: 2007-07
• Last Update Submitted: 2007-07-03
• Last Update Posted: 2007-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59651

Inclusion Criteria

• Newborn

Exclusion Criteria

• Infant/child

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Neonatal mortality rate

Secondary Outcome Measures

Name	Time	Method
Cost of delivering the intervention, per newborn
Changes in behavioral indicators
Change in program coverage

Trial Locations

Locations (1)

King George's Medical College; 🇮🇳 Lucknow, Uttar Pradesh, India