Operations Research to Improve Newborn Health

Pregnancy Complications Clinical Trial

Official title:

Operations Research to Improve Newborn Health and Survival in the (INHP-II) Area of CARE/India

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00198887
• Other study ID #: H.22.02.08.30.A2
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: July 3, 2007
• Start date: January 2003
• Est. completion date: October 2006

Study information

• Verified date: July 2007
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59651
• Est. completion date: October 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Newborn

Exclusion Criteria:

• Infant/child

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pregnancy Complications

Intervention

Procedure:
• Operations research

Locations

Country	Name	City	State
India	King George's Medical College	Lucknow	Uttar Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal mortality rate
Secondary	Cost of delivering the intervention, per newborn
Secondary	Changes in behavioral indicators
Secondary	Change in program coverage