ClinicalTrials.gg
Status unknownNCT03386747STBVUpdated Dec 29, 2017

Survive and Thrive Boa Vista Early Childhood Program

An interventional study of Home visits to improve parenting behaviors and Center based parenting groups in Neonatal Death and Mental Competency, sponsored by University of Sao Paulo. Status unknown at 1 site in Brazil. Per ClinicalTrials.gov, last updated 2017-12-29.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
15,000
Allocation
Randomized
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Neonatal Death
  • Mental Competency

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Keywords

  • child development
  • neonatal mortality
03

In context

Perinatal Death

120 studies on the registry are indexed under Perinatal Death; 25 are open to participants now.

This study's planned enrollment of 15,000 is above the median of 427 across 84 interventional studies indexed under Perinatal Death.

Browse Perinatal Death studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • pregnant women living in the urban area of Boa Vista

at LEAST ONE of the following vulnerability criteria

  1. bolsa família or other social cash transfer program recipient
  2. household income per capita less than half of minimum wage
  3. previous exposure to domestic or sexual violence before.

Exclusion criteria

Exclusion Criteria:

  • women living outside of Boa Vista urban area
  • women not meeting social vulnerability criteria above
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
15,000 participants (estimated)

Study arms

  • Experimental
    Home Visiting Group

    Intervention: Home visits to improve parenting behaviors

    Behavioral: Home visits to improve parenting behaviors

  • Experimental
    Center based parenting group

    Intervention: Center based parenting groups

    Behavioral: Center based parenting groups

  • No intervention
    control group

    The rest of pregnant women and their children who will not receive the intervention

Interventions

  • BehavioralHome visits to improve parenting behaviors

    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.

  • BehavioralCenter based parenting groups

    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.

06

What researchers measure

Primary outcomes

  1. Overall child development - PRIDI score

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

    Time frame: Age 2 - year 3 of the study

Secondary outcomes

  1. Neonatal mortality

    Probability of death between day 0 and day 27 after birth

    Time frame: 3 years

07

Study locations

1 site
  • Faculdade de Medicina da Universidade de São Paulo
    São Paulo, SP 01246903, Brazil
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2017 (actual). Primary completion is estimated for Dec 2019, 24 months after the start.

Of 36 non-industry interventional studies with no phase under Perinatal Death, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 41. This study's planned 24 months is below that.

Counting every sponsor, half of 36 studies reached it within 29 months; a quarter within 13 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 13, 2017
First posted
Dec 29, 2017
StartActual
Dec 1, 2017
Primary completionEst.
Dec 1, 2019
CompletionEst.
Dec 1, 2020
Last update
Dec 29, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03386747
Collaborators
The University of The West Indies, International Centre for Diarrhoeal Disease Research, Bangladesh, Inter-American Development Bank, Swiss Tropical & Public Health Institute
Responsible party
Alexandra Brentani (Professor, University of Sao Paulo) — Principal investigator
First posted
Dec 29, 2017
Start date
Dec 1, 2017
Primary completion
Dec 1, 2019 (estimated)
Completion
Dec 1, 2020 (estimated)
Last update
Dec 29, 2017

Study contacts

Alexandra Brentani, PhD
principal investigator · University of Sao Paulo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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