Operations Research to Improve Newborn Health

This study has been completed.
Sponsor:
Information provided by:
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00198887
First received: September 12, 2005
Last updated: July 3, 2007
Last verified: July 2007
  Purpose

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.


Condition Intervention
Pregnancy Complications
Procedure: Operations research

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Operations Research to Improve Newborn Health and Survival in the (INHP-II) Area of CARE/India

Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Neonatal mortality rate

Secondary Outcome Measures:
  • Cost of delivering the intervention, per newborn
  • Changes in behavioral indicators
  • Change in program coverage

Enrollment: 59651
Study Start Date: January 2003
Study Completion Date: October 2006
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Newborn

Exclusion Criteria:

  • Infant/child
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00198887

Locations
India
King George's Medical College
Lucknow, Uttar Pradesh, India
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Investigators
Principal Investigator: Mathuram Santosham, MD Johns Hopkins Bloomberg School of Public Health
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00198887     History of Changes
Other Study ID Numbers: H.22.02.08.30.A2
Study First Received: September 12, 2005
Last Updated: July 3, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
newborn
operations research
newborn survival
Neonatal illness/mortality
Delivery complications

Additional relevant MeSH terms:
Pregnancy Complications

ClinicalTrials.gov processed this record on August 25, 2014