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Neonatal DeathSTBVNCT03386747

Survive and Thrive Boa Vista Early Childhood Program

A study testing Home visits to improve parenting behaviors and Center based parenting groups in people with Neonatal Death and Mental Competency, run by University of Sao Paulo at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The proposed project will tackle the two most salient problems for children under 5 in Brazil: the continued high rates of neonatal mortality, and the large disparities in early childhood development. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Neonatal Death, Mental Competency
What is being tested?
Home visits to improve parenting behaviors and Center based parenting groups
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15,000 participants
Where
1 siteBrazil
Study dates
1 Dec 2017to 1 Dec 2020
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

  • pregnant women living in the urban area of Boa Vista
  • at LEAST ONE of the following vulnerability criteria
  • bolsa família or other social cash transfer program recipient
  • household income per capita less than half of minimum wage
  • previous exposure to domestic or sexual violence before.

Who cannot join

  • women living outside of Boa Vista urban area
  • women not meeting social vulnerability criteria above

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Faculdade de Medicina da Universidade de São Paulo

    São Paulo, São Paulo, 01246903

Other trials in Brazil

About this study

Official title: Survive and Thrive in Brazil: Boa Vista Early Childhood Program

The proposed project will tackle the two most salient problems for children under 5 in Brazil: the continued high rates of neonatal mortality, and the large disparities in early childhood development. We propose to extend and scale up previously tested and validated home visiting programs to the city of Boa Vista in the north region of Brazil. The core intervention of the program will be home visits or group meetings to mothers and caregivers by trained child development agents. At the core of the program is a detailed curriculum, which contains gestation and age-specific topics of child health and development to be discussed with caregivers at each encounter.

Read the detailed description

Even though much progress has been achieved in child mortality globally, relatively minor improvements have been realized in the first four weeks of children's life generally referred to as the neonatal period. Each year, four million infants die within the first 28 days of their life globally. As pointed out in the Lancet's neonatal survival series, 3 million neonatal deaths could be prevented each year by low-cost interventions. In Brazil, more than 25,000 newborns die each year within the first 28 days of their life, with a majority of deaths occurring in the first week. Previous studies suggest that one of the most effective ways to prevent such deaths are home visiting programs, which support mothers in the first weeks of infant's lives, promote breastfeeding and kangaroo mother care, and ensure appropriate medical care when needed. From a child health and child development perspective, optimal outcomes appear only feasible if continued support is provided to mothers from pregnancy throughout the first years of children's life. Home-based visits and support have become increasingly recognized as a both crucial and highly cost-effective strategy to achieve such outcomes.

The objective of this project is to extend and scale up the previously tested and validated home visiting programs to the city of Boa Vista. At the core of this program is a detailed curriculum, which contains gestation and age-specific topics of child health and development to be discussed with caregivers at each home visit. The intervention package will start in the third trimester of pregnancy and feature to sessions per month up to age 3 years.

This curriculum will be delivered through two separate - and randomly assigned - platforms: home visits through trained Child Development Agents (CDAs), and center-based delivery of the same delivery to groups of caregivers. The pilot study in Sao Paulo suggests that each CDA can handle approximately 40 families, visiting each caregiver twice per month. Visits will be initiated during the second trimester of pregnancy. The visits during pregnancy will not be a substitute for prenatal care but are designed to prepare mothers for babies and set up a relationship for a closer follow-up after birth. In Brazil, as well as globally, the numbers of pre-term deliveries and stillbirth is rather large, 20% of mature stillbirths (more than 37 weeks of gestation, more than 2.5 Kg) so the pre-natal care can be improved clearly. The visits would also occur during the neonatal period, when the largest proportional of under 5 mortality happens. This would be the first component of the program, addressing maternal and perinatal/neonatal mortality. Particular attention will be given to mothers after birth, with two special visits scheduled for the first week after birth focusing on maternal mental health; breastfeeding as well as kangaroo mother care when appropriate. Such visitation programs have been successfully tested within the family health strategy, and will be further reinforced and complemented by the new visitation program.

The city of Boa Vista has a population of approximately 330,000 people, with, 22,377 families (~30%) currently receiving social cash transfers under the bolsa familia program. The city is comparable to the national average in terms of the observed poverty rates, and roughly average in terms of its size. Infant mortality rate is estimated at 14.2 per 1000 live births, with 21% of births given by teenage mothers and 15% of infants born preterm.

The proposed project will exclusively target the most vulnerable households currently supported by the bolsa familia social cash transfer program. According to municipality estimates, about 5000 children are born each year in eligible households.

Being tested
Home visits to improve parenting behaviors, Center based parenting groups
Keywords
child development, neonatal mortality
Medical subject headings
Perinatal Death

What participants receive

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

  • Home visits to improve parenting behaviorsBehavioural

    Caregivers will be visited twice per month starting from the third trimester in pregnancy up to age three to discuss important health and development behaviors.

  • Center based parenting groupsBehavioural

    Caregivers will be invited to early childhood development groups. Groups will meet at nearby centers twice per month. Caregivers will be invited to participate starting from the third trimester up to age 3 of the child.

Study groups in NCT03386747
Study groupRoleWhat they receive
Home Visiting GroupExperimentalIntervention: Home visits to improve parenting behaviors
Receives: Behavioral: Home visits to improve parenting behaviors
Center based parenting groupExperimentalIntervention: Center based parenting groups
Receives: Behavioral: Center based parenting groups
control groupNo interventionThe rest of pregnant women and their children who will not receive the intervention

What is being measured

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

  1. Overall child development - PRIDI score

    Children's overall development will be assessed using the PRIDI child development assessment tool.

    Measured: Age 2 - year 3 of the study

Secondary outcomes (1)
  1. Neonatal mortality

    Probability of death between day 0 and day 27 after birth

    Measured: 3 years

Timeline

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

  1. First posted29 Dec 2017
  2. Study start1 Dec 2017
  3. Primary completion1 Dec 2019 (estimated)
  4. Study completion1 Dec 2020 (estimated)

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
15,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03386747
Sponsor's protocol ID
TTS180818280
Acronym
STBV
Status last verified
Dec 2017
First submitted
13 Dec 2017
Last updated
29 Dec 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Brentani A, Ferrer APS, Bessa L, Chang S, Walker S, Powell C, Hamadani J, Grisi S, Fink G. Survive and Thrive in Brazil: The Boa Vista Early Childhood Program: study protocol of a stepped-wedge, randomized controlled trial. Trials. 2020 May 7;21(1):390. doi: 10.1186/s13063-020-4217-3.

    PubMed 32381097

Questions about this trial

What is this clinical trial studying?

A study testing Home visits to improve parenting behaviors and Center based parenting groups in people with Neonatal Death and Mental Competency, run by University of Sao Paulo at 1 site in Brazil.

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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Dec 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 Brazil. 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?

Results are not available in the source record.

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?

Overall child development - PRIDI score (time frame: Age 2 - year 3 of the study). 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 NCT03386747, which also lists 1 linked publication.

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 29 Dec 2017; AzTrials last refreshed its copy on 31 Oct 2026.

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