Evidence map›Paper›PMID 35259172›Full record

Trial reportPLoS neglected tropical diseases2022

Improving neurodevelopment in Zika-exposed children: A randomized controlled trial.

Randall Waechter, Kemi S Burgen, Bianca Punch, Roberta Evans, Karen Blackmon, Trevor Noël, Michelle Fernandes, Barbara Landon

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PLoS neglected tropical diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04697147 (Rescuing Neurodevelopment in Zika-Exposed Infants in Grenada), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.8field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04697147 nacompletednot on this map

Rescuing Neurodevelopment in Zika-Exposed Infants in Grenada

TypeinterventionalSponsorWindward Islands Research and Education FoundationRan2018 to 2020Enrolled148ConditionsZika Virus Infection, Neurocognitive Deficit, Development, Child, Neurodevelopmental AbnormalityArmsConscious Discipline-Based Environmental Enrichment Intervention
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 1 institution in 3 countries.

Randall WaechterDepartment of Neuroscience, Physiology, and Behavioral Sciences; School of Medicine; St George's University; Grenada, West Indies.ORCID 0000-0002-3872-4245
Kemi S BurgenWindward Islands Research and Education Foundation; St. George's University; Grenada, West Indies.ORCID 0000-0002-5756-024X
Bianca PunchWindward Islands Research and Education Foundation; St. George's University; Grenada, West Indies.ORCID 0000-0001-6954-2762
Roberta EvansWindward Islands Research and Education Foundation; St. George's University; Grenada, West Indies.ORCID 0000-0002-8310-7721
Karen BlackmonWindward Islands Research and Education Foundation; St. George's University; Grenada, West Indies.
Trevor NoëlWindward Islands Research and Education Foundation; St. George's University; Grenada, West Indies.
Michelle FernandesWindward Islands Research and Education Foundation; St. George's University; Grenada, West Indies.ORCID 0000-0002-0051-3389
Barbara LandonWindward Islands Research and Education Foundation; St. George's University; Grenada, West Indies.
St. George's University · GD

Funding

Rescuing Neurodevelopment in Zika-exposed ChildrenR21HD093551 · NICHD · WINDWARD ISLANDS RESEARCH & ED FDN · PI FERNANDES, MICHELLE, LANDON, BARBARA · 2018 to 2019
$303k
Medical Research Council MR/V029169/1NICHD NIH HHS R21 HD093551
6 · The paper itself

Abstract

backgroundWhile microcephaly is a significant adverse outcome of prenatal exposure to the Zika virus (ZIKV), subtle malformations of cortical development (MCD) have been observed in Zika-exposed children (ZEC), including delays in language, cognition, and motor domains, and visual acuity deficits. Interventions within the first 1,000 days of life can significantly improve developmental outcomes. This study examined a 12-week Responsive Caregiving Intervention on neurodevelopmental outcomes in 24-30-month-old ZEC. METHODOLOGY/PRINCIPAL

findingsA randomized controlled trial was implemented in Grenada, West Indies using an existing ZIKV cohort surveillance study. When children in that study turned 24 months, baseline child neurodevelopmental measures and caregiver interviews were administered. Caregivers who agreed to participate in the 12-week Responsive Caregiving Intervention, implemented when children were 24-30 months of age, were randomly assigned to the Intervention or Waitlist Control group. Children in both groups were re-assessed on the neurodevelopmental measures post-intervention. CONCLUSIONS/SIGNIFICANCE: 233 children from the ZIKV surveillance study met inclusion criteria, of which n = 80 declined participation, n = 42 did not complete the Intervention, and n = 72 missed follow-up assessments given strict timelines in the study design. The final sample for analysis was N = 13 children in the Intervention group and N = 26 children in the Control group. A GEE model analysis showed significantly higher language (p = 0.021) and positive behaviour (p = 0.005) scores for children in the Intervention group compared to the Control group. The Intervention had a medium effect on child language (d = 0.66) and a large effect on positive behaviour (d = 0.83). A 12-week Responsive Caregiving Intervention Programme significantly improves language and positive behaviour scores in 30-month-old normocephalic children who were exposed to ZIKV in utero. The programme provides an option for mothers of ZIKV-exposed children who are seeking an evidence-based neurodevelopmental intervention regardless of known impact of the virus on cortical formation.

trial registrationThe study was registered with clinicaltrials.gov (NCT04697147).

Indexed as

MicrocephalyPregnancy Complications, InfectiousZika VirusZika Virus InfectionChildChild, PreschoolFemaleGrenadaHumansInfantPregnancy

Identifiers

PMID35259172
PMCPMC8903297
OpenAlexW4220723832

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.