NCT00136708

Brief Summary

In developing countries, neonatal death from birth asphyxia is a major problem. This study will be conducted in several countries to determine if the combined Neonatal Resuscitation Program/Essential Newborn Care Program compared to the new World Health Organization (WHO) basic perinatal care education of health care providers (Essential Newborn Care Program) results in reduced mortality due to perinatal asphyxia.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120,009

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2005

Longer than P75 for not_applicable

Geographic Reach
6 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

July 31, 2014

Status Verified

July 1, 2014

Enrollment Period

3.3 years

First QC Date

August 25, 2005

Last Update Submit

July 29, 2014

Conditions

Asphyxia Neonatorum

Keywords

Global NetworkNeonatal mortalityAsphyxiaMaternal and child healthInternationalZambiaPakistanIndiaDemocratic Republic of CongoUruguayGuatemalaArgentinaNeonatal resuscitation

Outcome Measures

Primary Outcomes (1)

  • Neonatal mortality

    7 days

Secondary Outcomes (7)

  • Neonatal mortality due to perinatal asphyxia

    7 days

  • Hypoxic ischemic encephalopathy

    7 days

  • Need for advanced resuscitation

    7 days

  • Apgar score at 5 minutes

    5 minutes

  • Perinatal mortality at 7 days

    7 days

  • +2 more secondary outcomes

Study Arms (2)

NRP Training (Intervention)

EXPERIMENTAL

Training in AAP neonatal resuscitation training program

Procedure: Neonatal Resuscitation

Control

OTHER
Procedure: Neonatal Resuscitation

Interventions

Neonatal ResuscitationPROCEDURE
ControlNRP Training (Intervention)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Live births with a weight ≥ 1500 grams (community minimum)
  • Infants born in participating communities

You may not qualify if:

  • Stillbirths
  • Infants with suspected/confirmed lethal malformations (e.g. anencephaly, Trisomy 13 or 18, or cyanotic or left-sided congenital heart disease that will not be repaired)
  • Any infant who is transported/brought to the center after delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Buenos Aires, Argentina

Location

Unknown Facility

Guatemala City, Guatemala

Location

Unknown Facility

Bhubaneswar, Odisha, India

Location

Unknown Facility

Belagavi, India

Location

Unknown Facility

Karachi, Pakistan

Location

Unknown Facility

Kinshasa, Republic of the Congo

Location

Unknown Facility

Lusaka, Zambia

Location

Related Publications (3)

  • Matendo R, Engmann C, Ditekemena J, Gado J, Tshefu A, Kinoshita R, McClure EM, Moore J, Wallace D, Carlo WA, Wright LL, Bose C. Reduced perinatal mortality following enhanced training of birth attendants in the Democratic Republic of Congo: a time-dependent effect. BMC Med. 2011 Aug 4;9:93. doi: 10.1186/1741-7015-9-93.

    PMID: 21816050DERIVED

  • Carlo WA, Goudar SS, Jehan I, Chomba E, Tshefu A, Garces A, Parida S, Althabe F, McClure EM, Derman RJ, Goldenberg RL, Bose C, Hambidge M, Panigrahi P, Buekens P, Chakraborty H, Hartwell TD, Moore J, Wright LL; First Breath Study Group. High mortality rates for very low birth weight infants in developing countries despite training. Pediatrics. 2010 Nov;126(5):e1072-80. doi: 10.1542/peds.2010-1183. Epub 2010 Oct 11.

    PMID: 20937655DERIVED

  • Carlo WA, Goudar SS, Jehan I, Chomba E, Tshefu A, Garces A, Parida S, Althabe F, McClure EM, Derman RJ, Goldenberg RL, Bose C, Krebs NF, Panigrahi P, Buekens P, Chakraborty H, Hartwell TD, Wright LL; First Breath Study Group. Newborn-care training and perinatal mortality in developing countries. N Engl J Med. 2010 Feb 18;362(7):614-23. doi: 10.1056/NEJMsa0806033.

    PMID: 20164485DERIVED

Related Links

MeSH Terms

Conditions

Asphyxia NeonatorumAsphyxia

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDeathPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and Injuries

Study Officials

  • Waldemar Carlo, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 29, 2005

Study Start

March 1, 2005

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

July 31, 2014

Record last verified: 2014-07

Locations

RE(1)PA(1)IN(2)ZA(1)GU(1)AR(1)