AzTrials
AzTrials

Infectious DiseaseNCT00198705

Community Based Interventions to Reduce Neonatal Mortality in Bangladesh

A study testing Improved management of severe neonatal infections in people with Infectious Disease, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This project delivers, promotes and facilitates services related to pregnancy, delivery and newborn care. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Infectious Disease
What is being tested?
Improved management of severe neonatal infections
How many people
10,670 participants
Where
1 siteBangladesh
Study dates
Jun 2003to Aug 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • participants consenting for the home-based care model area
  • participants who consent for household adequacy survey
  • participants who consent from clinic care model area

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site
  • ICDDR,B

    Dhaka

Other trials in Bangladesh

About this study

This project delivers, promotes and facilitates services related to pregnancy, delivery and newborn care.

Read the detailed description

The Project entitled "Community-Based Intervention to Reduce Neonatal Mortality in Bangladesh", also known as Projahnmo - I (Project to Advance the Health of Newborns and Mothers), is a partnership project of the Johns Hopkins Bloomberg School of Public Health (JHSPH), USA, with a number of Bangladeshi organizations including: a) the Ministry of Health and Family Welfare (MOHFW) of the Government of Bangladesh (GoB), b) the Centre for Health and Population Research (ICDDRB), c) Save the Children/USA, Bangladesh Field Office (SC/BFO), d) Shimantik, a Bangladeshi NGO, e) BRAC/Bangladesh, f) Dhaka Shishu Hospital and g) the Institute of Child and Mother Health (ICMH). The project is funded through four mechanisms: 1) USAID Global funding to cover expenses of JHSPH to design and to provide technical assistance in the implementation and evaluation of the various components of the project, 2) SNL/SC funding to JHSPH to sub-contract the Bangladeshi institutions listed above to support implementation of the intervention component of the project, 3) USAID/Bangladesh funding to ICDDRB to cover the cost of implementation of the research and evaluation component of the project, 4) the Bangladeshi government's contribution in-terms of staff time, supplies, and facilities. This partnership between multiple research institutions and donors brings diverse, rich and unique experiences and expertise. It ensures the relevance of the project and increases the likelihood of scaling up and sustaining the intervention.

The goals of Projahnmo I are to: (a) introduce two models of delivering improved maternal and newborn care in rural Bangladesh; (b) measure each model's impact on neonatal mortality and other relevant indicators; (c) assess the cost effectiveness and feasibility of the two models.

The project includes two intervention arms with two different service delivery models, home care (HC) and clinic care (CC). Community health workers (CHWs) and community mobilizers (CMs) deliver the Birth and Newborn Care Preparedness (BNCP) package, which includes counseling during the antenatal period, delivery care, care of the baby during delivery, postnatal care, and continued counseling and education during the neonatal period. Service provision also includes making referral for sick newborns and playing the role of facilitator for behavior change in the households and communities. The strategic approaches used also include pregnancy surveillance and community-level mobilization of specific target groups, such as pregnant women, senior female family members, husbands and other targeted local advocacy meetings. In both arms, community-based meetings conducted by CMs focus on facilitating involvement of the mothers and other family members in the decision-making process and making them aware of the importance of proper antenatal care, delivery care, postpartum care, and newborn care. In the HC model, counseling is conducted at home with pregnant women and their families by CHWs. In the CC arm, women receive these messages through community meetings by CMs and during antenatal check-up (ANC) visits by governmental primary health workers and paramedics. In CC arms, CMs identify community change agents to assist in creating awareness and promoting behavior change. In addition, traditional birth attendants (TBAs), who commonly attend home deliveries in the study communities, have been oriented on newborn health.

Being tested
Improved management of severe neonatal infections
Medical subject headings
Communicable Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Improved management of severe neonatal infectionsBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neonatal mortality rate

Secondary outcomes (2)
  1. Neonatal colonization with antibiotic-resistant bacteria

  2. Cost of providing the intervention services per neonate

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2005 (estimated)
  2. Study startJun 2003
  3. Primary completionJul 2007
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
10,670 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00198705
Sponsor's protocol ID
H.22.00.12.06.BX
Status last verified
Sep 2014
First submitted
12 Sep 2005
Last updated
16 Sep 2014
Results posted
No

Publications

  • Baqui AH, Ahmed S, El Arifeen S, Darmstadt GL, Rosecrans AM, Mannan I, Rahman SM, Begum N, Mahmud AB, Seraji HR, Williams EK, Winch PJ, Santosham M, Black RE; Projahnmo 1 Study Group. Effect of timing of first postnatal care home visit on neonatal mortality in Bangladesh: a observational cohort study. BMJ. 2009 Aug 14;339:b2826. doi: 10.1136/bmj.b2826.

    PubMed 19684100
  • Baqui AH, El-Arifeen S, Darmstadt GL, Ahmed S, Williams EK, Seraji HR, Mannan I, Rahman SM, Shah R, Saha SK, Syed U, Winch PJ, Lefevre A, Santosham M, Black RE; Projahnmo Study Group. Effect of community-based newborn-care intervention package implemented through two service-delivery strategies in Sylhet district, Bangladesh: a cluster-randomised controlled trial. Lancet. 2008 Jun 7;371(9628):1936-44. doi: 10.1016/S0140-6736(08)60835-1.

    PubMed 18539225

Questions about this trial

What is this clinical trial studying?

A study testing Improved management of severe neonatal infections in people with Infectious Disease, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neonatal mortality rate. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00198705, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2014.

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