Premature BirthIBAIPNCT04685356
Effect of the IBAIP in Preterm Infants Neurodevelopment
A study testing IBAIP : Infant Behaviour Assessment and Intervention Program, Standard Support and Ages and Stages Questionnaire (ASQ) in people with Premature Birth, run by University Hospital, Brest at 9 sites in France.
Trial summary
Mortality in very preterm infants has decreased significantly over the past twenty years. However, neuromotor, behavioral and cognitive development disorders are more common in these children born before 33 weeks of gestation as compared to term born infants. Read more about this study
- Who is it for?
- Ages 25 to 32 weeks
- Conditions the study is for
- Premature Birth
- What is being tested?
- IBAIP : Infant Behaviour Assessment and Intervention Program, Standard Support and Ages and Stages Questionnaire (ASQ)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 9 sitesFrance
- Study dates
- 8 Nov 2022to 8 Jan 2028
- Phase
- Interventional
- 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 25 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants born (including multiple pregnancies) at a gestational age between 25 weeks +0 days and 32 weeks + 6days.
- Written informed consent of at least one of the parents / legal guardian or 2 parents / legal guardians depending on the family context
- Normal neurological examination between 36 and 41 weeks of corrected age
Who cannot join
- Intraventricular hemorrhage (III or IV), periventricular leukomalacia
- Brain MRI abnormalities performed after 36 weeks of corrected age
- Life-threatening pathology
- Severe congenital abnomality
- Severe maternal pathology (physical and / or mental)
- Parents whose native language is not French
- Participation in another interventional study on the management of post-hospital neurodevelopment disorders
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
France9 sites, 7 recruiting
- Recruiting
CHU Angers
Angers
Bertrand LEBOUCHER, 2.41.35.44.07 ext. +33, BeLeboucher@chu-angers.fr
- Recruiting
CHU Besançon
Besançon
Emma BECUWE-GOSSELIN, 3.81.21.40.83 ext. +33, ebecuwe@chu-besancon.fr
- Recruiting
CHU Brest
Brest, 29200
Jean-Michel ROUE
jean-michel.roue@chu-brest.fr
- Recruiting
CHU Caen
Caen, 14033
Valérie DATIN-DORRIERE, PhD, 2.31.27.25.64 ext. +33, datindorriere-v@chu-caen.fr
- Recruiting
CHU Grenoble
Grenoble
Blandine REBEILLE-BORGELLA, +33 4 76 76 55 77, brebeilleborgella@chu-grenoble.fr
- Withdrawn
CHU Nantes
Nantes, 44000
- Withdrawn
CHU Rennes
Rennes
- Recruiting
CHRU Strasbourg
Strasbourg
Pierre KUHN, 3.88.12.77.76 ext. +33, Pierre.Kuhn@chru-strasbourg.fr
- Recruiting
CHU Tours
Tours, 37000
Delphine MITANCHEZ, 2.47.47.92.48 ext. +33, delphine.mitanchez@univ-tours.fr
About this study
Official title: Effect of the Infant Behavioral Assessment and Intervention Program (IBAIP) in Preterm Infants on Neurodevelopment at 2 Years Corrected Age
Mortality in very preterm infants has decreased significantly over the past twenty years. However, neuromotor, behavioral and cognitive development disorders are more common in these children born before 33 weeks of gestation as compared to term born infants.
These neurodevelopmental disorders include difficulties with self-regulation, tone, posture or poor quality movements as well as inadequate responses to sensory simulation.
Read more
Post-hospital discharge follow-up and interventionsof children born very preterm ares very heterogeneous in France. They are mainly carried out in a rehabilitation center, based on caregivers whereas IBAIP is carried out at home and family centered.
Early interventions during hospitalization or after discharge appear potentially of great interest in improving the neurodevelopemental outcome of the very preterm infants. Several early interventions have been developed and evaluated in other countries. These interventions are designed to be used early in life, mainly during the first 3 years of life, and are based on brain plasticity and intense synaptogenesis during this period of life.
The IBAIP (Infant Behavior Assessment and Intervention Program) was developed on the same theoretical foundations as the NIDCAP (Neonatal Individualized Development Care and Assessment Program). IBAIP consists of providing the child and his family with an intervention, at home, starting just before hospital discharge up to a 6 months corrected age. .The aim of IBAIP is to support developmental functions including infant's self-regulation and focus on improving the responsiveness of parents' infant interactions.
Read the detailed description
This program consists of providing intervention, by a IBAIP trained and certified healthcare professional, with the child and his family, starting a few days before hospitalization discharge (hospital or home care) and continuing at home until the corrected age of 6 months. It focuses on the child's behaviors and consists of assisting the family in its interactions with the child so that these are adapted and responsive to the child's development needs over time through repeated interventions.
A cluster randomization will be used meaning the centers are randomized, not the individual patients. The centers will be randomized before the inclusion of patients in order to allow the physiotherapists or psychomotor therapists to be trained and certified to the IBAIP before the start of the trial.
Visit 1: Upon discharge from hospital, follow-up as part of standard care (control group) with at least 1 medical consultation per month during the first 6 months or according to the IBAIP program (experimental group) with one intervention before discharge from hospital and at home after hospital discharge, with1 session once a month up to 6 months corrected age (i.e. 6 to 8 sessions) in addition to standard care.
Visit 2: At 6 months corrected age, parents' response to the PSI (Parenting Stress Index) questionnaire.
Visit 3: At two years corrected age :
- Assessment of the development quotient obtained on the BSID-IV scale during a consultation with a neuro-psychologist or pediatrician.
- Parents' response to the PSI (Parenting Stress Index) questionnaire
- Parents' response to the ASQ (Ages and Stages Questionnaire
- Conditions
- Premature Birth
- Being tested
- IBAIP : 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)
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBAIP : Infant Behaviour Assessment and Intervention ProgramOther
The IBAIP intervention program consists of providing an intervention with the child and their family, at home, upon discharge from hospital and up to a corrected age of 6 months. Interventions therefore take place at the early stage of the child's brain development. The intervention is performed by a IBAIP-trained and certified physiotherapist or psychomotor therapist trained , at the rate of one session per month over a period of approximately 6 to 8 months (6 months of corrected age). The session takes place in the child's usual living environment, at home, in the presence of at least one of the parents. It focuses on the child's behaviors and consists of assisting the family in its interactions with the child so that these are adapted and responsive to the child's development needs over time through repeated interventions.
Standard SupportOther
One medical consultation per month and, if indicated by the physician providing follow-up, medical specialist and / or paramedical (physiotherapy, speech therapy, psychomotricity, etc.) consultations including interventions in the case of developmental delays
Ages and Stages Questionnaire (ASQ)Other
Global development screening tool
Parenting Stress Index (PSI)Other
Index used to detect difficulties sufficiently significant that they might require psychosocial intervention
Bayley Scales of Infant and Toddler Development (BSID-IV)Other
This test was designed to measure the development of infants / young children. This assessment examines all spheres of child development, identifies children with developmental delay and assesses children's developmental performance compared to their peers.
| Study group | Role | What they receive |
|---|---|---|
| IBAIP Group | Experimental | Children benefiting from assessment and intervention providing by a healthcare professional (physiotherapist or psychomotor therapist) trained and certified for IBAIP. This care will take place upon discharge from the hospital at the rate of one session per month for 6 months. The sessions will take place in the presence of at least one of the parents and at home. These children will also benefit from standard follow-up (medical follow-up, paramedical or specialized medical support depending on the development and needs). Receives: Other: IBAIP : Infant Behaviour Assessment and Intervention Program; Other: Ages and Stages Questionnaire (ASQ); Other: Parenting Stress Index (PSI); Other: Bayley Scales of Infant and Toddler Development (BSID-IV) |
| Control group | Active comparator | Children benefiting from standard care upon discharge from hospital with 1 medical consultation per month and, medical sepcialist and / or paramedical(physiotherapy, speech therapy, psychomotricity, etc.). consultations if indicated by the physician providing follow-up Receives: Other: Standard Support; Other: Ages and Stages Questionnaire (ASQ); Other: Parenting Stress Index (PSI); Other: Bayley Scales of Infant and Toddler Development (BSID-IV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of the Infant Behavior Assessment and Intervention Program Program (IBAIP) in very preterm infants (< 33 weeks of gestation) on neurodevelopment at the corrected age of 2 years
Patient neurodevelopment will be assessed using the Bayley Scales of Infant and Toddler Development (BSID-IV) scale. This test studies the different notions of development: cognitive, language, motor skills, socio-emotional, behavioral, communication and autonomy.
Measured: 2 years of corrected age
Secondary outcomes (3)
To assess the effect of IBAIP on the 5 sub-scores of BSID-IV: cognitive, language, motor, socio-emotional and behavioral adaptive
The BSID-IV scale can be analyzed at the level of each of these subscales. The different scores obtained allow us to identify precisely at what level the effect on neurodevelopment was the most significant.
Measured: 2 years of corrected age
To assess the effect on the stress level of mothers and fathers
To assess through the response to the Parental Stress Index. This questionnaire consists in 120 items using a 5-level Likert scale. It allows the assessment of life stress score, parental stress and child stress.
Measured: 2 years of corrected age
Parental assessment of psychomotor development
Ages and Stages questionnaire completed by the parents to assess the child's neurodevelopment in 5 areas (fine motor skills, gross motor skills, communication, problem solving, individual or social skills).
Measured: 2 years of corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start8 Nov 2022
- Primary completion8 Jan 2028 (estimated)
- Study completion8 Jan 2028 (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 Premature BirthStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685356
- Sponsor's protocol ID
- 29BRC17.0219
- Acronym
- IBAIP
- Status last verified
- Jun 2026
- First submitted
- 22 Dec 2020
- Last updated
- 26 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Publications
Smith M, Kuhn P, Thiriez G, Debillon T, Datin-Dorriere V, Leboucher B, Mitanchez D, Courtois-Communier E, Sizun J, Roue JM. 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. BMJ Open. 2025 Sep 4;15(9):e088167. doi: 10.1136/bmjopen-2024-088167.
PubMed 40908020
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Infant Behavioral Assessment and Intervention Program (IBAIP) in Preterm Infants on Neurodevelopment at 2 Years Corrected Age
- ClinicalTrials.gov ID
- NCT04685356
- Acronym / sponsor ID
- IBAIP / 29BRC17.0219
- Conditions
- Premature Birth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 8 Jan 2028 (estimated)
- Study completion
- 8 Jan 2028 (estimated)
- First posted
- 28 Dec 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.
Mortality in very preterm infants has decreased significantly over the past twenty years. However, neuromotor, behavioral and cognitive development disorders are more common in these children born before 33 weeks of gestation as compared to term born infants.
These neurodevelopmental disorders include difficulties with self-regulation, tone, posture or poor quality movements as well as inadequate responses to sensory simulation.
Post-hospital discharge follow-up and interventionsof children born very preterm ares very heterogeneous in France. They are mainly carried out in a rehabilitation center, based on caregivers whereas IBAIP is carried out at home and family centered.
Early interventions during hospitalization or after discharge appear potentially of great interest in improving the neurodevelopemental outcome of the very preterm infants. Several early interventions have been developed and evaluated in other countries. These interventions are designed to be used early in life, mainly during the first 3 years of life, and are based on brain plasticity and intense synaptogenesis during this period of life.
The IBAIP (Infant Behavior Assessment and Intervention Program) was developed on the same theoretical foundations as the NIDCAP (Neonatal Individualized Development Care and Assessment Program). IBAIP consists of providing the child and his family with an intervention, at home, starting just before hospital discharge up to a 6 months corrected age. .The aim of IBAIP is to support developmental functions including infant's self-regulation and focus on improving the responsiveness of parents' infant interactions.
Detailed description
This program consists of providing intervention, by a IBAIP trained and certified healthcare professional, with the child and his family, starting a few days before hospitalization discharge (hospital or home care) and continuing at home until the corrected age of 6 months. It focuses on the child's behaviors and consists of assisting the family in its interactions with the child so that these are adapted and responsive to the child's development needs over time through repeated interventions.
A cluster randomization will be used meaning the centers are randomized, not the individual patients. The centers will be randomized before the inclusion of patients in order to allow the physiotherapists or psychomotor therapists to be trained and certified to the IBAIP before the start of the trial.
Visit 1: Upon discharge from hospital, follow-up as part of standard care (control group) with at least 1 medical consultation per month during the first 6 months or according to the IBAIP program (experimental group) with one intervention before discharge from hospital and at home after hospital discharge, with1 session once a month up to 6 months corrected age (i.e. 6 to 8 sessions) in addition to standard care.
Visit 2: At 6 months corrected age, parents' response to the PSI (Parenting Stress Index) questionnaire.
Visit 3: At two years corrected age :
- Assessment of the development quotient obtained on the BSID-IV scale during a consultation with a neuro-psychologist or pediatrician.
- Parents' response to the PSI (Parenting Stress Index) questionnaire
- Parents' response to the ASQ (Ages and Stages Questionnaire
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBAIP Group | Experimental | Other: IBAIP : Infant Behaviour Assessment and Intervention Program, Other: Ages and Stages Questionnaire (ASQ), Other: Parenting Stress Index (PSI), Other: Bayley Scales of Infant and Toddler Development (BSID-IV)Children benefiting from assessment and intervention providing by a healthcare professional (physiotherapist or psychomotor therapist) trained and certified for IBAIP. This care will take place upon discharge from the hospital at the rate of one session per month for 6 months. The sessions will take place in the presence of at least one of the parents and at home. These children will also benefit from standard follow-up (medical follow-up, paramedical or specialized medical support depending on the development and needs). |
| Control group | Active comparator | Other: Standard Support, Other: Ages and Stages Questionnaire (ASQ), Other: Parenting Stress Index (PSI), Other: Bayley Scales of Infant and Toddler Development (BSID-IV)Children benefiting from standard care upon discharge from hospital with 1 medical consultation per month and, medical sepcialist and / or paramedical(physiotherapy, speech therapy, psychomotricity, etc.). consultations if indicated by the physician providing follow-up |
Who may qualify
- Ages
- 25 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm infants born (including multiple pregnancies) at a gestational age between 25 weeks +0 days and 32 weeks + 6days.
- Written informed consent of at least one of the parents / legal guardian or 2 parents / legal guardians depending on the family context
- Normal neurological examination between 36 and 41 weeks of corrected age
Key exclusion criteria (7 listed)
- Intraventricular hemorrhage (III or IV), periventricular leukomalacia
- Brain MRI abnormalities performed after 36 weeks of corrected age
- Life-threatening pathology
- Severe congenital abnomality
- Severe maternal pathology (physical and / or mental)
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 |
|---|---|---|
| IBAIP : Infant Behaviour Assessment and Intervention ProgramThe IBAIP intervention program consists of providing an intervention with the child and their family, at home, upon discharge from hospital and up to a corrected age of 6 months. Interventions therefore take place at the early stage of the child's brain development. The intervention is performed by a IBAIP-trained and certified physiotherapist or psychomotor therapist trained , at the rate of one session per month over a period of approximately 6 to 8 months (6 months of corrected age). The session takes place in the child's usual living environment, at home, in the presence of at least one of the parents. It focuses on the child's behaviors and consists of assisting the family in its interactions with the child so that these are adapted and responsive to the child's development needs over time through repeated interventions. | Other | IBAIP Group |
| Standard SupportOne medical consultation per month and, if indicated by the physician providing follow-up, medical specialist and / or paramedical (physiotherapy, speech therapy, psychomotricity, etc.) consultations including interventions in the case of developmental delays | Other | Control group |
| Ages and Stages Questionnaire (ASQ)Global development screening tool | Other | Control group, IBAIP Group |
| Parenting Stress Index (PSI)Index used to detect difficulties sufficiently significant that they might require psychosocial intervention | Other | Control group, IBAIP Group |
| Bayley Scales of Infant and Toddler Development (BSID-IV)This test was designed to measure the development of infants / young children. This assessment examines all spheres of child development, identifies children with developmental delay and assesses children's developmental performance compared to their peers. | Other | Control group, IBAIP Group |
Primary outcome
To assess the effect of the Infant Behavior Assessment and Intervention Program Program (IBAIP) in very preterm infants (< 33 weeks of gestation) on neurodevelopment at the corrected age of 2 years
Time frame: 2 years of corrected age
Patient neurodevelopment will be assessed using the Bayley Scales of Infant and Toddler Development (BSID-IV) scale. This test studies the different notions of development: cognitive, language, motor skills, socio-emotional, behavioral, communication and autonomy.
3 secondary outcomes
To assess the effect of IBAIP on the 5 sub-scores of BSID-IV: cognitive, language, motor, socio-emotional and behavioral adaptive
Time frame: 2 years of corrected age
To assess the effect on the stress level of mothers and fathers
Time frame: 2 years of corrected age
Parental assessment of psychomotor development
Time frame: 2 years of corrected age
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 26 Jun 2026.
- Derived from this study: PubMed 40908020Smith M, Kuhn P, Thiriez G, Debillon T, Datin-Dorriere V, Leboucher B, Mitanchez D, Courtois-Communier E, Sizun J, Roue JM. 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. BMJ Open. 2025 Sep 4;15(9):e088167. doi: 10.1136/bmjopen-2024-088167.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IBAIP : Infant Behaviour Assessment and Intervention Program, Standard Support and Ages and Stages Questionnaire (ASQ) in people with Premature Birth, run by University Hospital, Brest at 9 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 3 inclusion and 7 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 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 Jean-Michel ROUE, PhD (2.98.22.36.67 ext. +33, jean-michel.roue@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the effect of the Infant Behavior Assessment and Intervention Program Program (IBAIP) in very preterm infants (< 33 weeks of gestation) on neurodevelopment at the corrected age of 2 years (time frame: 2 years of corrected age). 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 NCT04685356, 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 26 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.