Community-based perinatal and newborn care in rural Pakistan: a cluster randomised controlled trial
| ISRCTN | ISRCTN16247511 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16247511 |
| Secondary identifying numbers | 01006HNI |
- Submission date
- 09/09/2005
- Registration date
- 01/02/2006
- Last edited
- 02/03/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jose Martines
Scientific
Scientific
World Health Organization
20 Avenue Appia
Geneva-27
CH 1211
Switzerland
| martinesj@who.int |
Study information
| Study design | Cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Scientific title | |
| Study objectives | The promotion of improved newborn care by first level health workers (traditional birth attendants, lady health workers and midwives) together with increased community participation in newborn care will lead to a substantial reduction in neonatal and perinatal mortality. |
| Ethics approval(s) | Ethics approval received on the 21st June 2005. |
| Health condition(s) or problem(s) studied | Newborn sepsis, birth asphyxia, pneumonia |
| Intervention | 1. Improved newborn care by first level health workers (traditional birth attendants, lady health workers and midwives) 2. Increased community participation in newborn care For further information please contact Dr Martines at the address listed below or the principal investigator: Dr Zulfiqar Bhutta Department of Paediatric and Child Health Aga Khan University Stadium Road Karachi P.O. Box 3500 Pakistan Email: zulfiqar.bhutta@aku.edu |
| Intervention type | Other |
| Primary outcome measure | 1. Newborn mortality 2. Perinatal mortality |
| Secondary outcome measures | 1. Early initiation of breastfeeding 2. Exclusive breastfeeding |
| Overall study start date | 01/08/2002 |
| Completion date | 30/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 36,000 |
| Key inclusion criteria | All newborns in the study community are eligible for inclusion. |
| Key exclusion criteria | Refusal to participate. |
| Date of first enrolment | 01/08/2002 |
| Date of final enrolment | 30/06/2008 |
Locations
Countries of recruitment
- Pakistan
- Switzerland
Study participating centre
World Health Organization
Geneva-27
CH 1211
Switzerland
CH 1211
Switzerland
Sponsor information
The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
Research organisation
Research organisation
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
| martinesj@who.int | |
| Website | http://www.who.int |
"ROR" |
https://ror.org/01f80g185 |
Funders
Funder type
Research organisation
The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
No information available
Saving Newborn Lives (SNL) (USA)
No information available
United Nations Children's Fund (UNICEF)
No information available
Government of Pakistan (Pakistan)
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? |
|---|---|---|---|---|---|
| Results article | results | 29/01/2011 | Yes | No |
