Neonatal MortalityPhase 3NewhintsNCT00623337
Ghana Newborn Home Visits Neonatal Mortality Trial
A Phase 3 study testing Home visits in people with Neonatal Mortality, run by London School of Hygiene and Tropical Medicine at 1 site in Ghana.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 12 months
- Conditions the study is for
- Neonatal Mortality
- What is being tested?
- Home visits
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,000 participants
- Where
- 1 siteGhana
- Study dates
- Jan 2009to Apr 2010
- Phase
- Phase 3
- 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 1 day to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All live births in trial area
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cluster Randomised Trial to Evaluate the Impact of Routine Home Visits to Provide a Package of Essential Newborn Care Interventions in the Third Trimester of Pregnancy and the 1st Week of Life on Neonatal Mortality in Rural Ghana
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.
Read the detailed description
Study area: The NEWHINTS trial will be conducted in 6 contiguous districts with an area of 12,000km in the central Brong Ahafo Region of rural Ghana. The area is predominantly rural and has a total population of approximately 600,000 persons, with more than 100,000 women of reproductive age. The study area is multi-ethnic and education levels are low. It is served by 4 district hospitals, and a small number of additional government health centres and private facilities. More than 15,000 babies are born within the area each year; the neonatal mortality rate is about 30 per 1000 live births. Over 50% of births occur at home and these home deliveries account for a large proportion of all neonatal deaths. A potential cadre of CHWs, who are currently working in the region and whose capacity could be expanded to include home visits, are Community Based Surveillance Volunteers (CBSVs); CBSVs currently assist the DHMTs with the registration of births, disease detection and community mobilization.
Intervention: The intervention is being developed by a collaborative group from Kintampo Health Research Centre, the District Health Management Teams (DHMTs) of the 6 districts and the London School of Hygiene and Tropical Medicine. It will comprise of:
- Training CBSVs to identify pregnant women in the community and to conduct 2 home visits during pregnancy and 3 in the first week of life of the infant on days 1, 3 and 7:
- to promote birth preparedness and prompt careseeking during pregnancy and childbirth
- to promote essential perinatal and neonatal care practices
- to identify and refer very low birth weight or sick babies
- to give advice on special treatment for low birth weight babies
- to teach neonatal danger signs and encourage prompt careseeking
- to promote key child survival interventions for infancy (breastfeeding, bednets, immunisations) CBSVs will provide support through dialogue and problem-solving. Other family members key in decision-making concerning childbirth and newborn care will be invited to take part in the discussions.
- Developing a sustainable supervisory and remuneration structure for the CBSVs;
- Various intervention support activities inc
- Sensitisation of health facility staff to intervention messages and approach#
- Sensitisation of traditional birth attendants (TBAs)
- Meetings with village leaders to introduce intervention aims and activities
- Community durbars
Study design: Formative research consisting of in-depth interviews, focus-groups and pilot trials of home visits/improved practices will be conducted to improve the feasibility and optimality of the planned intervention and to design training and intervention support materials. A cluster randomised controlled trial design with 98 health zones as units of randomisation will be used to evaluate the impact on neonatal mortality, careseeking during pregnancy and childbirth and newborn care practices. The intervention will be implemented in half of the zones, chosen at random, and evaluated over an 18 month period. Impact data will come from ongoing 4-weekly surveillance of all women of child-bearing age and their infants including verbal post mortems, conducted as part of the ongoing "ObaapaVitA" Vitamin A and maternal mortality trial. A process evaluation will be conducted over 3-monthly intervals to assess the coverage and quality of the services provided and the response to the services.
- Conditions
- Neonatal Mortality
- Being tested
- Home visits
- Keywords
- care seeking, pregnancy and childbirth, newborn care practices, low birth weight babies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home visitsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Newhints | Experimental | Home visits Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal mortality rate
Measured: deaths within 28 days of birth
Secondary outcomes (1)
% mothers carrying out promoted newborn care practices
Measured: within 28 days of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2008 (estimated)
- Study startJan 2009
- Primary completionMar 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Neonatal MortalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Kintampo Health Research Centre, Ghana, Institute of Child Health
- Responsible party
- Sponsor
- Investigators
- Betty R Kirkwood, Principal investigator, London School of Hygiene and Tropical MedicineZelee E Hill, Principal investigator, Institute of Child Health, LondonAlexander Manu, Principal investigator, Kintampo Health Research Centre (KHRC)Charlotte Tawiah, Principal investigator, KHRCSeth Owusu-Agyei, Principal investigator, KHRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623337
- Sponsor's protocol ID
- Newhints
- Other IDs
- WHO: C6-181-512,# 007, SNL: Sub-grant # 251, LSHTM: EPNPVE28 & EPNPVP18
- Acronym
- Newhints
- Status last verified
- Feb 2010
- First submitted
- 15 Feb 2008
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19057567Lohela 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.
PubMed 27297010Manu 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.
PubMed 27297006Vesel 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.
PubMed 23667161Kirkwood 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.
PubMed 23578528Kirkwood 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.
PubMed 20478070
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster Randomised Trial to Evaluate the Impact of Routine Home Visits to Provide a Package of Essential Newborn Care Interventions in the Third Trimester of Pregnancy and the 1st Week of Life on Neonatal Mortality in Rural Ghana
- ClinicalTrials.gov ID
- NCT00623337
- Acronym / sponsor ID
- Newhints / Newhints
- Conditions
- Neonatal Mortality
- Keywords
- care seeking, pregnancy and childbirth, newborn care practices, low birth weight babies
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Kintampo Health Research Centre, Ghana, Institute of Child Health
- Study start
- Jan 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 26 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study area: The NEWHINTS trial will be conducted in 6 contiguous districts with an area of 12,000km in the central Brong Ahafo Region of rural Ghana. The area is predominantly rural and has a total population of approximately 600,000 persons, with more than 100,000 women of reproductive age. The study area is multi-ethnic and education levels are low. It is served by 4 district hospitals, and a small number of additional government health centres and private facilities. More than 15,000 babies are born within the area each year; the neonatal mortality rate is about 30 per 1000 live births. Over 50% of births occur at home and these home deliveries account for a large proportion of all neonatal deaths. A potential cadre of CHWs, who are currently working in the region and whose capacity could be expanded to include home visits, are Community Based Surveillance Volunteers (CBSVs); CBSVs currently assist the DHMTs with the registration of births, disease detection and community mobilization.
Intervention: The intervention is being developed by a collaborative group from Kintampo Health Research Centre, the District Health Management Teams (DHMTs) of the 6 districts and the London School of Hygiene and Tropical Medicine. It will comprise of:
- Training CBSVs to identify pregnant women in the community and to conduct 2 home visits during pregnancy and 3 in the first week of life of the infant on days 1, 3 and 7:
- to promote birth preparedness and prompt careseeking during pregnancy and childbirth
- to promote essential perinatal and neonatal care practices
- to identify and refer very low birth weight or sick babies
- to give advice on special treatment for low birth weight babies
- to teach neonatal danger signs and encourage prompt careseeking
- to promote key child survival interventions for infancy (breastfeeding, bednets, immunisations) CBSVs will provide support through dialogue and problem-solving. Other family members key in decision-making concerning childbirth and newborn care will be invited to take part in the discussions.
- Developing a sustainable supervisory and remuneration structure for the CBSVs;
- Various intervention support activities inc
- Sensitisation of health facility staff to intervention messages and approach#
- Sensitisation of traditional birth attendants (TBAs)
- Meetings with village leaders to introduce intervention aims and activities
- Community durbars
Study design: Formative research consisting of in-depth interviews, focus-groups and pilot trials of home visits/improved practices will be conducted to improve the feasibility and optimality of the planned intervention and to design training and intervention support materials. A cluster randomised controlled trial design with 98 health zones as units of randomisation will be used to evaluate the impact on neonatal mortality, careseeking during pregnancy and childbirth and newborn care practices. The intervention will be implemented in half of the zones, chosen at random, and evaluated over an 18 month period. Impact data will come from ongoing 4-weekly surveillance of all women of child-bearing age and their infants including verbal post mortems, conducted as part of the ongoing "ObaapaVitA" Vitamin A and maternal mortality trial. A process evaluation will be conducted over 3-monthly intervals to assess the coverage and quality of the services provided and the response to the services.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Newhints | Experimental | Behavioral: Home visitsHome visits |
| Control | No intervention | –Community based surveillance volunteers will continue with current duties eg urging attendance at immunisation clinics and child health weeks |
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All live births in trial area
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home visitsHome 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 | Behavioural | Newhints |
Primary outcome
Neonatal mortality rate
Time frame: deaths within 28 days of birth
1 secondary outcome
% mothers carrying out promoted newborn care practices
Time frame: within 28 days of birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
- Background: PubMed 19057567Hill 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.
- Derived from this study: PubMed 27297010Lohela 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.
- Derived from this study: PubMed 27297006Manu 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.
- Derived from this study: PubMed 23667161Vesel 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.
- Derived from this study: PubMed 23578528Kirkwood 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.
- Derived from this study: PubMed 20478070Kirkwood 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.
Related trials for Neonatal Mortality
Enrolling by invitation
Accelerating Maternal and Newborn Survival: The AMANI Study
Maternal and Perinatal Death Surveillance and Response (MPDSR) Implementation, Maternal Mortality
RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine
Recruiting
Clean Trial - Chlorination to Reduce Enteric and Antibiotic Resistant Infections in Neonates
Sepsis, Neonatal Mortality
Not yet recruiting
Magnesium Sulphate for Neonatal Asphyxia and Length of Hospital Stay
Duration of Hospitalization, Neonatal Mortality Rate
Not yet recruitingObservational study
Predictors of Outcomes in Pulmonary Hypertension of the Newborn
Hypertension, Pulmonary, Infant, Newborn, Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Betty R Kirkwood principal investigator
London School of Hygiene and Tropical Medicine
Zelee E Hill principal investigator
Institute of Child Health, London
Alexander Manu principal investigator
Kintampo Health Research Centre (KHRC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Home visits in people with Neonatal Mortality, run by London School of Hygiene and Tropical Medicine at 1 site in Ghana.
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 1 inclusion and 1 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 24 Aug 2017. 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 Ghana. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (time frame: deaths within 28 days of birth). 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 NCT00623337, which also lists 6 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 24 Aug 2017.