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Operations Research to Improve Newborn Health

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ClinicalTrials.gov Identifier: NCT00198887
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : July 6, 2007
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Pregnancy Complications Procedure: Operations research

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59651 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Operations Research to Improve Newborn Health and Survival in the (INHP-II) Area of CARE/India
Study Start Date : January 2003
Study Completion Date : October 2006
Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Neonatal mortality rate

Secondary Outcome Measures :
  1. Cost of delivering the intervention, per newborn
  2. Changes in behavioral indicators
  3. Change in program coverage

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Newborn

Exclusion Criteria:

  • Infant/child
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00198887     History of Changes
Other Study ID Numbers: H.22.02.08.30.A2
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: July 6, 2007
Last Verified: July 2007

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