NCT00623337

Brief Summary

Introduction: Just under four million infants die each year before reaching one month of age; neonatal deaths now account for 38% of the 10.8 million deaths among children younger than 5 years of age. Tackling neonatal mortality is essential if the millennium development goal to reduce by 2015 overall child mortality by two-thirds from its levels in 1990 is to be achieved. Postnatal care for mothers and neonates in developing countries, particularly when deliveries occur at home, is either not available or is of poor quality. Trained community workers are considered by many to be pivotal to newborn care in the community, as they can act as catalysts for community actions and also be providers of care.Reductions in neonatal mortality have been slower in Sub-Saharan Africa than in any other region, and no evaluations of the effectiveness and feasibility of home visits in reducing neonatal mortality have been conducted. Trial aim: To link with the Ghana Health Service to develop a feasible and sustainable intervention to improve newborn care practices and careseeking during pregnancy and childbirth, and to identify and refer very low birth weight and/or sick babies, through routine home-visits by community health workers (CHWs), and by so doing reduce neonatal mortality.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 26, 2008

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

August 24, 2017

Status Verified

February 1, 2010

Enrollment Period

1.2 years

First QC Date

February 15, 2008

Last Update Submit

August 23, 2017

Conditions

Neonatal Mortality

Keywords

care seekingpregnancy and childbirthnewborn care practiceslow birth weight babies

Outcome Measures

Primary Outcomes (1)

  • Neonatal mortality rate

    deaths within 28 days of birth

Secondary Outcomes (1)

  • % mothers carrying out promoted newborn care practices

    within 28 days of birth

Study Arms (2)

Newhints

EXPERIMENTAL

Home visits

Behavioral: Home visits

Control

NO INTERVENTION

Community based surveillance volunteers will continue with current duties eg urging attendance at immunisation clinics and child health weeks

Interventions

Home visitsBEHAVIORAL

Home visits by community based surveillance volunteers (2 during pregnancy \& 3 during 1st week of life) to promote facility delivery, careseeking during pregnancy and childbirth and essential newborn care practices and to identify \& refer sick babies

Newhints

Eligibility Criteria

Age1 Day - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All live births in trial area

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kintampo Health Research Centre

Kintampo, Brong Ahafo Region, Ghana

Location

Related Publications (6)

  • Hill Z, Manu A, Tawiah-Agyemang C, Gyan T, Turner K, Weobong B, Ten Asbroek AH, Kirkwood BR. How did formative research inform the development of a home-based neonatal care intervention in rural Ghana? J Perinatol. 2008 Dec;28 Suppl 2:S38-45. doi: 10.1038/jp.2008.172.

    PMID: 19057567BACKGROUND

  • Lohela TJ, Nesbitt RC, Manu A, Vesel L, Okyere E, Kirkwood B, Gabrysch S. Competence of health workers in emergency obstetric care: an assessment using clinical vignettes in Brong Ahafo region, Ghana. BMJ Open. 2016 Jun 13;6(6):e010963. doi: 10.1136/bmjopen-2015-010963.

    PMID: 27297010DERIVED

  • Manu A, Hill Z, Ten Asbroek AH, Soremekun S, Weobong B, Gyan T, Tawiah-Agyemang C, Danso S, Amenga-Etego S, Owusu-Agyei S, Kirkwood BR. Increasing access to care for sick newborns: evidence from the Ghana Newhints cluster-randomised controlled trial. BMJ Open. 2016 Jun 13;6(6):e008107. doi: 10.1136/bmjopen-2015-008107.

    PMID: 27297006DERIVED

  • Vesel L, Manu A, Lohela TJ, Gabrysch S, Okyere E, Ten Asbroek AH, Hill Z, Agyemang CT, Owusu-Agyei S, Kirkwood BR. Quality of newborn care: a health facility assessment in rural Ghana using survey, vignette and surveillance data. BMJ Open. 2013 May 9;3(5):e002326. doi: 10.1136/bmjopen-2012-002326.

    PMID: 23667161DERIVED

  • Kirkwood BR, Manu A, ten Asbroek AH, Soremekun S, Weobong B, Gyan T, Danso S, Amenga-Etego S, Tawiah-Agyemang C, Owusu-Agyei S, Hill Z. Effect of the Newhints home-visits intervention on neonatal mortality rate and care practices in Ghana: a cluster randomised controlled trial. Lancet. 2013 Jun 22;381(9884):2184-92. doi: 10.1016/S0140-6736(13)60095-1. Epub 2013 Apr 9.

    PMID: 23578528DERIVED

  • Kirkwood BR, Manu A, Tawiah-Agyemang C, ten Asbroek G, Gyan T, Weobong B, Lewandowski RE, Soremekun S, Danso S, Pitt C, Hanson K, Owusu-Agyei S, Hill Z. NEWHINTS cluster randomised trial to evaluate the impact on neonatal mortality in rural Ghana of routine home visits to provide a package of essential newborn care interventions in the third trimester of pregnancy and the first week of life: trial protocol. Trials. 2010 May 17;11:58. doi: 10.1186/1745-6215-11-58.

    PMID: 20478070DERIVED

MeSH Terms

Interventions

House Calls

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Betty R Kirkwood

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

  • Zelee E Hill

    Institute of Child Health, London

    PRINCIPAL INVESTIGATOR

  • Alexander Manu

    Kintampo Health Research Centre (KHRC)

    PRINCIPAL INVESTIGATOR

  • Charlotte Tawiah

    KHRC

    PRINCIPAL INVESTIGATOR

  • Seth Owusu-Agyei

    KHRC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2008

First Posted

February 26, 2008

Study Start

January 1, 2009

Primary Completion

March 1, 2010

Study Completion

April 1, 2010

Last Updated

August 24, 2017

Record last verified: 2010-02

Locations

GH(1)