AttachMent Preterm in the Loire Infant Follow-up Team

NCT04304846 | Recruiting

• 1 other identifier: 49RC19_0132
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to describe the attachment representations of children born prematurely at age 3 and 5 with regard to their neurocognitive and behavioral development.

Conditions

Preterm Birth

Keywords

Prematurity; Attachment

Outcome Measures

Primary Outcomes (1)

• Attachment Story Completion Task

  The evaluation of attachment representations will be realized at two stages of development, using attachment story stems to complete (Attachment Story Completion Task; Bretherton, Ridgeway \& Cassidy, 1990), which is the gold standard tool for measuring this variable between the ages of 3 and 7. Four scores measuring security, deactivation, hyperactivation and disorganization are obtained with the coding system described by Miljkovitch (Miljkovitch et al. 2003). Score on each scale vary from -1 to +1.

  Three and five years after preterm birth

Secondary Outcomes (6)

• Attachment Multiple Model Interview (AMMI)

  Three and five years after preterm birth

• Parenting Stress Index (PSI) Scale

  Three and five years after preterm birth

• Post-traumatic stress disorder Questionnaire (PPQ)

  Three and five years after preterm birth

• Ages and Stages Questionnaires® (AQS) Questionnaires

  Three and five years after preterm birth

• Strengths and Difficulties Questionnaire (SDQ)

  Three and five years after preterm birth

Study Arms (1)

AMPLIFy group

Mother, premature child and teacher will complete questionnaires and interviews on attachment, maternal stress and child behavior

Other: Questionnaires and interviews

Interventions

Questionnaires and interviews OTHER

List of questionnaires: ASQ, PSI, PPQ, SDQ, GSA and AMMI score obtained from mother during two separated interviews for the mother and the child at 3 and 5 years old

AMPLIFy group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children born prematurely in the French region Pays de la Loire and included in the cohort 'Réseau Grandir Ensemble en Pays de la Loire'.

You may qualify if:

• Children born in the neonatal reanimation department of Angers and Nantes University Hospitals
• Extrem preterm infants (term of birth less than or equal to 28 weeks of amenorrhea)
• Children included in the regional monitoring network for vulnerable newborns (Réseau Grandir Ensemble en Pays de la Loire, RGE)
• Children with a follow-up consultation at age 3 scheduled as part of the classic RGE follow-up on the Angers and Nantes University Hospitals
• Informed consent dated and signed by the parents or the holder of the parental authority
• Affiliated to a Social Security scheme

You may not qualify if:

• Child with severe neurocognitive impairment or severe autism trait-type behavioral disorder in the 2-year RGE follow-up evaluation

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (2)

University Hospital of Angers

Angers, 49933, France

RECRUITING

University Hospital of Nantes

Nantes, France

NOT YET RECRUITING

Related Publications (1)

• Riquin E, Sandnes R, Bacro F, Vinay A, Miljkovitch R, Rouger V, Rakotonjanahary J, Gascoin G, Muller JB. A Prospective Observational Study to Assess Attachment Representations With Regard to Neurocognitive and Behavioral Outcomes in Children Born Very Prematurely in the Loire Infant Follow-Up Team (LIFT Cohort). Front Pediatr. 2022 Jul 13;10:896103. doi: 10.3389/fped.2022.896103. eCollection 2022.

  PMID: 35903159 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Surveys and Questionnaires; Interviews as Topic

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Elise Riquin, MD

  University Hospital of Angers

  PRINCIPAL INVESTIGATOR

• Géraldine Gascoin, MD

  University Hospital of Angers

  STUDY DIRECTOR

Central Study Contacts

Denise Jolivot, MD

CONTACT

33-2-41-35-58-08; DeJolivot@chu-angers.fr

Sybille Lazareff, CRA

CONTACT

33-2-41-35-33-42; SyLazareff@chu-angers.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 11, 2020
• Study Start: January 7, 2021
• Primary Completion: January 6, 2025
• Study Completion (Estimated): January 6, 2027
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)