Preterm BirthAMPLIFyNCT04304846
AttachMent Preterm in the Loire Infant Follow-up Team
An observational study of Preterm Birth, run by University Hospital, Angers at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Questionnaires and interviews
- How many people
- 90 participants
- Where
- 2 sitesFrance
- Study dates
- 7 Jan 2021to 6 Jan 2027
- How long will I take part?
- 18 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
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'.
Who may be able to join
- 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
Who cannot join
- Child with severe neurocognitive impairment or severe autism trait-type behavioral disorder in the 2-year RGE follow-up evaluation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
University Hospital of Angers
Angers, 49933
Géraldine Gascoin, MD, GeGascoin@chu-angers.fr
Elise Riquin, MD, Elise.Riquin@chu-angers.fr
- Not yet recruiting
University Hospital of Nantes
Nantes
Jean-Baptiste Muller, MD, Jeanbaptiste.MULLER@chu-nantes.fr
About this study
Official title: Attachment Representations of Children Born Prematurely in the Loire Infant Follow-up Team Cohort
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.
Read the detailed description
Whether they are born at term or prematurely, from birth, children seek contact with caregivers and establish privileged relationships with them. These attachment relationships are gradually established and, from the end of the first year, interindividual differences can be observed according to temperament, quality of interactions with adults and responses to children's needs for proximity and comfort.
Prematurity is a situation that can disrupt parent-child interactions. The physiological characteristics of the premature infant attenuate and distort his/her stress signals. Visual interactions are shorter, alertness is more labile and reactivity is less clear than that of babies born at term. In such situations of stress and trauma, maternal sensitivity and responsiveness can be affected. In addition, changes in the quality of mother-child interactions have been reported, with more controlling maternal behavior. This maternal trend has been associated with behavioral disorders in children, such as eating disorders or lack of interest in social communication. More frequent disruptions of maternal caregiving associated with relational withdrawal in the child have also been shown in the case of prematurity.
We hypothesize that the experience of establishing relationships with parents in a context of extreme prematurity can alter the development of secure attachment representations in the child and that maternal representations and their possible interactions with prematurity factors prevent or contribute to the development of insecure or disorganized attachment in the child. We also hypothesize that disorganized attachment representations are associated with somatic, environmental, affective, and neurodevelopmental complications (motor, cognitive and behavioral).
- Conditions
- Preterm Birth
- Being tested
- Questionnaires and interviews
- Keywords
- Prematurity, Attachment
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires and interviewsOther
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
| Study group | Role | What they receive |
|---|---|---|
| AMPLIFy group | Mother, premature child and teacher will complete questionnaires and interviews on attachment, maternal stress and child behavior Receives: Other: Questionnaires and interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three and five years after preterm birth
Secondary outcomes (6)
Attachment Multiple Model Interview (AMMI)
The AMMI is a semi-structured interview, which assesses attachment representations regarding specific relationships including relationships with mother, father, and romantic partners (Miljkovitch, Moss, Bernier, Pascuzzo, \& Sander, 2015). Scores vary from 0 to 8 for the security, deactivation, and hyperactivation scales and from 0 to 16 for the disorganization.
Measured: Three and five years after preterm birth
Parenting Stress Index (PSI) Scale
The PSI is a 120-item self-report questionnaire assessing parenting stress in two main domains: The Parent Domain (51 items) measures stress related to parental functioning, the Child Domain (50 items) measures child qualities and characteristics that contribute to stress in the parent-child system. The PSI contains an additional Life Stress scale (19 items), which will not be used in the study. Scores vary from 50 to 250 in the Parent Domain and from 51 to 255 in the Child Domain. In both domains, higher scores indicate more stress.
Measured: Three and five years after preterm birth
Post-traumatic stress disorder Questionnaire (PPQ)
A 14-item self-report questionnaire assessing the level of mothers' post-traumatic stress. A score between 0 and 56 is calculated.
Measured: Three and five years after preterm birth
Ages and Stages Questionnaires® (AQS) Questionnaires
The ASQ-3 (and ASQ-5) assess 5 aspects of child development: communication, gross motor skills, fine motor skills, problem solving, and personal-social skills. Each aspect is evaluated through 6 questions. If the answer is yes, score = 10, sometimes = 5 and not yet = 0. The total scores obtained with the ASQ-3 and ASQ-5 range from 0 to 300.
Measured: Three and five years after preterm birth
Strengths and Difficulties Questionnaire (SDQ)
The SDQ is a brief parent-report behavioral screening questionnaire for 3-16 year olds. It comprises 20 items relative to 5 categories: emotional problems, conduct problems, hyperactivity/inattention, peer relationship problems and prosocial behavior. The total score obtained with the SDQ is comprised between 0 and 50.
Measured: Three and five years after preterm birth
Global School Adaptation (GSA) Score
The GSA score is an instrument designed for teachers to assess children's abilities and behavior in the classroom with 20 questions. Six questions investigate linguistic competence, five questions investigate non-verbal abilities, eight questions address children's behavior in the classroom and the final question invites the teacher to give his/her prognosis of the child's future adaptation to school life. Total scores vary from 20 to 60.
Measured: Five years after preterm birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start7 Jan 2021
- Primary completion6 Jan 2025 (estimated)
- Study completion6 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 18 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Elise Riquin, MD, Principal investigator, University Hospital of AngersGéraldine Gascoin, MD, Study director, University Hospital of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304846
- Sponsor's protocol ID
- 49RC19_0132
- Acronym
- AMPLIFy
- Status last verified
- Jun 2024
- First submitted
- 10 Mar 2020
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35903159
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attachment Representations of Children Born Prematurely in the Loire Infant Follow-up Team Cohort
- ClinicalTrials.gov ID
- NCT04304846
- Acronym / sponsor ID
- AMPLIFy / 49RC19_0132
- Conditions
- Preterm Birth
- Keywords
- Prematurity, Attachment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 6 Jan 2025 (estimated)
- Study completion
- 6 Jan 2027 (estimated)
- First posted
- 11 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Whether they are born at term or prematurely, from birth, children seek contact with caregivers and establish privileged relationships with them. These attachment relationships are gradually established and, from the end of the first year, interindividual differences can be observed according to temperament, quality of interactions with adults and responses to children's needs for proximity and comfort.
Prematurity is a situation that can disrupt parent-child interactions. The physiological characteristics of the premature infant attenuate and distort his/her stress signals. Visual interactions are shorter, alertness is more labile and reactivity is less clear than that of babies born at term. In such situations of stress and trauma, maternal sensitivity and responsiveness can be affected. In addition, changes in the quality of mother-child interactions have been reported, with more controlling maternal behavior. This maternal trend has been associated with behavioral disorders in children, such as eating disorders or lack of interest in social communication. More frequent disruptions of maternal caregiving associated with relational withdrawal in the child have also been shown in the case of prematurity.
We hypothesize that the experience of establishing relationships with parents in a context of extreme prematurity can alter the development of secure attachment representations in the child and that maternal representations and their possible interactions with prematurity factors prevent or contribute to the development of insecure or disorganized attachment in the child. We also hypothesize that disorganized attachment representations are associated with somatic, environmental, affective, and neurodevelopmental complications (motor, cognitive and behavioral).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 18 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMPLIFy group | – | Other: Questionnaires and interviewsMother, premature child and teacher will complete questionnaires and interviews on attachment, maternal stress and child behavior |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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'.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Child with severe neurocognitive impairment or severe autism trait-type behavioral disorder in the 2-year RGE follow-up evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires and interviewsList 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 | Other | AMPLIFy group |
Primary outcome
Attachment Story Completion Task
Time frame: Three and five years after preterm birth
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.
6 secondary outcomes
Attachment Multiple Model Interview (AMMI)
Time frame: Three and five years after preterm birth
Parenting Stress Index (PSI) Scale
Time frame: Three and five years after preterm birth
Post-traumatic stress disorder Questionnaire (PPQ)
Time frame: Three and five years after preterm birth
Ages and Stages Questionnaires® (AQS) Questionnaires
Time frame: Three and five years after preterm birth
Strengths and Difficulties Questionnaire (SDQ)
Time frame: Three and five years after preterm birth
Global School Adaptation (GSA) Score
Time frame: Five years after preterm birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Derived from this study: PubMed 35903159Riquin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elise Riquin, MD principal investigator
University Hospital of Angers
Géraldine Gascoin, MD study director
University Hospital of Angers
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth, run by University Hospital, Angers at 2 sites in France.
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 6 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Denise Jolivot, MD (33-2-41-35-58-08, DeJolivot@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attachment Story Completion Task (time frame: Three and five years after preterm birth). 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 NCT04304846, 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 11 Jun 2024.