Community-based perinatal and newborn care in rural Pakistan: a cluster randomised controlled trial
| ISRCTN | ISRCTN16247511 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16247511 |
| Protocol serial number | 01006HNI |
| Sponsor | The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland) |
| Funders | The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland), Saving Newborn Lives (SNL) (USA), United Nations Children's Fund (UNICEF), Government of Pakistan (Pakistan) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Cluster randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. Newborn mortality |
| Key secondary outcome measure(s) |
1. Early initiation of breastfeeding |
| Completion date | 30/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 36000 |
| 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
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 | 29/01/2011 | Yes | No |
