Evidence map›Paper›PMID 40908020›Full record

ArticleBMJ open2025

Infant behavioural assessment and intervention program to support neurodevelopmental outcome of very preterm infants at two years corrected age: a cluster randomised controlled trial study protocol.

Meghan Smith, Pierre Kuhn, Gerard Thiriez, Thierry Debillon, Valérie Datin-Dorrière, Bertrand Leboucher, Delphine Mitanchez, Emmanuelle Courtois-Communier, Jacques Sizun, Jean-Michel Roué

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04685356 (Effect of the Infant Behavioral Assessment and Intervention Program), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT04685356 narecruitingnot on this map

Effect of the Infant Behavioral Assessment and Intervention Program (IBAIP) in Preterm Infants on Neurodevelopment at 2 Years Corrected Age

TypeinterventionalSponsorUniversity Hospital, BrestRan2022 to 2028Enrolled240ConditionsPremature BirthArmsIBAIP : Infant Behaviour Assessment and Intervention Program, Standard Support, Ages and Stages Questionnaire (ASQ), Parenting Stress Index (PSI), Bayley Scales of Infant and Toddler Development (BSID-IV)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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

10 authors.

Meghan SmithDepartement of Neonatal Medicine and Pediatric Critical Care Medecine, Brest University Hospital Centre, Brest, Bretagne, France.ORCID http://orcid.org/0000-0002-3442-2856
Pierre KuhnDepartement of Neonatal Medicine and Pediatric Critical Care Medecine, Strasbourg University Hospitals, Strasbourg, Grand Est, France.ORCID http://orcid.org/0000-0003-3132-481X
Gerard ThiriezDepartment of Neonatal and Pediatric Emergency, Besançon Regional University Hospital Center, Besancon, Bourgogne-Franche-Comté, France.
Thierry DebillonNeonatal Intensive Care Unit, Grenoble Alpes University Hospital, Grenoble, France.
Valérie Datin-DorrièreDepartment of Neonatology, University Hospital Centre Caen, Caen, Basse-Normandie, France.
Bertrand LeboucherDepartment of Neonatalogy and Neonatal Intensive Care, University Hospital Centre Angers, Angers, Pays de la Loire, France.
Delphine MitanchezDepartment of Neonatology, Regional University Hospital Centre Tours Bretonneau Hospital, Tours, Centre-Val de Loire, France.
Emmanuelle Courtois-CommunierBiostatistics and Methodology Team,Department of Clinical Research and Innovation, Brest University Hospital Centre, Brest, Brittany, France.
Jacques SizunDepartment of Neonatal Medicine, University Hospital Centre Toulouse, Toulouse, Occitanie, France.ORCID http://orcid.org/0000-0002-6985-6910
Jean-Michel RouéDepartement of Neonatal Medicine and Pediatric Critical Care Medecine, Brest University Hospital Centre, Brest, Bretagne, France jean-michel.roue@chu-brest.fr.ORCID http://orcid.org/0000-0002-5734-7254

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPreterm infants are at risk of developmental impairment, especially those born before 33 weeks gestational age. Many studies have shown a positive impact of early interventions on medical outcomes during hospitalisation, long-term cognitive development and parental anxiety. Infant Behavioral Assessment and Intervention Program (IBAIP) has shown positive effects on cognitive development but also on motor impairment in a Dutch cohort. We aim to confirm these results in a multicentric, cluster randomised controlled trial in a French setting. METHODS AND ANALYSIS: Eight French neonatal intensive care units (NICUs) will be randomised before study initiation to intervention or control group. We aim to include 240 infants born between 25 weeks and 33 weeks gestational age. IBAIP intervention comprises monthly home visits with a trained professional from hospital discharge until 6 months corrected age. Both groups receive standard care according to local organisation. The primary endpoint is composite cognitive score at 2 years corrected age using Bayley Scale of Infant Development Fourth Edition (BSID IV). Secondary endpoints include BSID IV subscores, Ages and Stages Questionnaire scores and parental stress. Analysis is in intention to treat. Univariate and multivariate analysis will be performed on primary and secondary endpoints. ETHICS AND DISSEMINATION: Informed consent from one or both parents will be necessary for all patients. Study results will be published in peer-reviewed scientific journals. If our hypothesis is confirmed, IBAIP could be implemented on a nationwide scale. The study was registered with clinicaltrials.gov (ID: 29BRC17.0219). TRIAL REGISTRATION NUMBER: NCT04685356.

Indexed as

Child DevelopmentInfant BehaviorInfant, Extremely PrematureInfant, PrematureChild, PreschoolCognitionFemaleFranceGestational AgeHumansInfantInfant, NewbornIntensive Care Units, NeonatalMaleMulticenter Studies as TopicParentsDevelopmental neurology & neurodisabilityNEONATOLOGYPAEDIATRICSPatient-Centered Care

Identifiers

PMID40908020
PMCPMC12414155

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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 OpenQuestion graph.