Uganda Newborn Survival Study: improving newborn health and survival through a community based intervention linked to health facilities

ISRCTN ISRCTN50321130
DOI https://doi.org/10.1186/ISRCTN50321130
Secondary identifying numbers N/A
Submission date
31/10/2009
Registration date
17/02/2010
Last edited
07/02/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof George Pariyo
Scientific

Makerere University
School of Public Health
College of Health Sciences
PO Box 7072
Kampala
-
Uganda

Phone +256 (0)41 453 0291
Email gpariyo@musph.ac.ug

Study information

Study designRandomised controlled cluster trial
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)Home
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleImproving newborn health and survival through a community based intervention linked to health facilities: a randomised controlled cluster trial
Study acronymUNEST
Study objectivesImplementation of an integrated care package of four home visits by a community health worker (CHW) during pregnancy and the neonatal period to deliver one on one health messages and promoting linkage to the health facility improves the following maternal-newborn care practices by at least 20% in two years amongst the target population in rural Uganda.

Further information can be found at:
http://www.ncbi.nlm.nih.gov/pubmed/18570672
http://www.ncbi.nlm.nih.gov/pubmed/19710561
Ethics approval(s)Uganda National Council of Science and Technology HS626 approved from the 20/08/2009 to 20/08/2010
Health condition(s) or problem(s) studiedMaternal and newborn health
InterventionThrough formative research around evidence-based practices, and dialogue with policy and technical advisors, we will construct a home-based neonatal care package implemented by the responsible Village Health Team member, effectively a Community Health Worker. This CHW will be trained to identify pregnant women and make four home visits: two before and two just after birth. Linkages will be made to facility care and targeted messages for home-care and care-seeking delivered. The project will improve care in health units to provide standardised care for the mother and the newborn in both intervention and comparison areas.

The control area is being given the current standard of care provided by the Government. However, health facility quality improvement initiatives are being provided in both control and intervention areas in order to standardise care but also for ethical reasons. This will enable sick newborns in the control area to access care.
Intervention typeOther
Primary outcome measure1. In ANC:
1.1. % of pregnant women attending ANC two, four or more times
1.2. % of pregnant women who know at least two danger signs of pregnancy
1.3. % of pregnant women who prepare for birth

2. In the intrapartum period:
2.1. % of pregnant women who have a skilled attendant at delivery
2.2. % of women who went to the HC in an emergency

3. In the post-natal period:
3.1. % of babies who are initiated on breastfeeding in the first 6 hours of birth
3.2. % of babies who are exclusively breastfed during the neonatal period
3.3. % of babies whose first bath was delayed for 6 and 24 hours
3.4. % of mothers who put nothing on the cord
3.5. % of mothers who know at least 3 neonatal danger signs
3.6. % women whose children were managed in skin to skin contact after delivery.
3.7. Effectiveness of sepsis management (special studies to determine: maternal and CHW knowledge, compliance and timing of referral, and adequacy of treatment following referral)
Secondary outcome measures1. Neonatal mortality
2. Perinatal mortality
Overall study start date01/07/2009
Completion date30/12/2011

Eligibility

Participant type(s)Mixed
Age groupAdult
SexFemale
Target number of participants65 villages, 70000 people
Key inclusion criteria1. Women of childbearing age
2. Pregnant women
3. Newly delivered women
4. Neonates and infants
Key exclusion criteriaRefusal to consent
Date of first enrolment01/07/2009
Date of final enrolment30/12/2011

Locations

Countries of recruitment

  • Uganda

Study participating centre

Makerere University
Kampala
-
Uganda

Sponsor information

Save the Children (USA)
Charity

2000 L Street NW
Suite 500
DC 20036 202.640.6661
Washington
2000
United States of America

Phone +1 (0)203 221 4030
Email twebster@savechildren.org
Website http://www.savechildren.org
ROR logo "ROR" https://ror.org/036jr6x18

Funders

Funder type

Charity

Save the Children (USA) (ref: UG01_232)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 15/11/2012 Yes No
Results article results 31/03/2015 Yes No
Results article results 31/03/2015 Yes No

Editorial Notes

07/02/2017: Publication reference added.
28/01/2016: Publication reference added.