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
Scientific
Makerere University
School of Public Health
College of Health Sciences
PO Box 7072
Kampala
-
Uganda
| Phone | +256 (0)41 453 0291 |
|---|---|
| gpariyo@musph.ac.ug |
Study information
| Study design | Randomised controlled cluster trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Home |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | 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) |
| Secondary outcome measures | 1. Neonatal mortality 2. Perinatal mortality |
| Overall study start date | 01/07/2009 |
| Completion date | 30/12/2011 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 65 villages, 70000 people |
| 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
-
Uganda
Sponsor information
Save the Children (USA)
Charity
Charity
2000 L Street NW
Suite 500
DC 20036 202.640.6661
Washington
2000
United States of America
| Phone | +1 (0)203 221 4030 |
|---|---|
| twebster@savechildren.org | |
| Website | http://www.savechildren.org |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
