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
Protocol serial number	N/A
Sponsor	Save the Children (USA)
Funder	Save the Children (USA) (ref: UG01_232)

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

Primary study design	Interventional
Study design	Randomised controlled cluster trial
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	Improving newborn health and survival through a community based intervention linked to health facilities: a randomised controlled cluster trial
Study acronym	UNEST
Study objectives	Implementation 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) studied	Maternal and newborn health
Intervention	Through 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 type	Other
Primary outcome measure(s)	1. 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)
Key secondary outcome measure(s)	1. Neonatal mortality 2. Perinatal mortality
Completion date	30/12/2011

Eligibility

Participant type(s)	Mixed
Age group	Adult
Sex	Female
Target sample size at registration	70000
Key inclusion criteria	1. Women of childbearing age 2. Pregnant women 3. Newly delivered women 4. Neonates and infants
Key exclusion criteria	Refusal to consent
Date of first enrolment	01/07/2009
Date of final enrolment	30/12/2011

Locations

Countries of recruitment

Uganda

Study participating centre

Makerere University

Kampala
-
Uganda

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	31/03/2015		Yes	No
Results article	results	31/03/2015		Yes	No
Protocol article	protocol	15/11/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

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