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Completed

NCT Number: NCT00198887

Operations Research to Improve Newborn Health

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King George's Medical College

Lucknow, Uttar Pradesh, India

About this study

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:

  • antenatal care,
  • iron-folate supplementation,
  • tetanus toxoid vaccination,
  • maternal nutrition and rest,
  • birth planning,
  • essential newborn care,
  • immediate and exclusive breastfeeding,
  • prevention of hypothermia,
  • aseptic cord care, and
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newborn

Exclusion criteria

  • Infant/child

Treatment and study plan

Operations research

Procedure

Primary outcomes

  1. Neonatal mortality rate

Secondary outcomes

  1. Cost of delivering the intervention, per newborn

  2. Changes in behavioral indicators

  3. Change in program coverage

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2006
First posted
Sep 20, 2005
Registry last updated
Jul 6, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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