Operations Research to Improve Newborn Health

NCT ID: NCT00198887

Last Updated: 2007-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59651 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2006-10-31

Brief Summary

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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

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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.

Conditions

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Pregnancy Complications

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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Operations research

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Newborn

Exclusion Criteria

* Infant/child
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role lead

Principal Investigators

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Mathuram Santosham, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

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King George's Medical College

Lucknow, Uttar Pradesh, India

Site Status

Countries

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India

Other Identifiers

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H.22.02.08.30.A2

Identifier Type: -

Identifier Source: org_study_id