Premature InfantVPINCT03093337
Psychomotor Therapy for Very Premature Infants
A study testing Early post hospital discharge psychomotor therapy in people with Premature Infant, run by University Hospital, Toulouse at 10 sites in France.
Trial summary
Our current reflexion is that sensory dys-stimulations, including vestibule-proprioceptive disorders and unbalanced between brain and brainstem maturation of the neonatal period involve an early deviant development for immature infants that will be cascaded through the brain scaffolding and later development. Read more about this study
- Who is it for?
- Ages 24 to 30 weeks
- Conditions the study is for
- Premature Infant
- What is being tested?
- Early post hospital discharge psychomotor therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 10 sitesFrance
- Study dates
- 1 Dec 2007to 8 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 24 to 30 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants with a gestational age between 24 and 30 weeks.
Who cannot join
- Infants with congenital disease,
- Infants with brain bleeding grade III-IV,
- Infants with periventricular leucomalacia,
- Infants whose mothers had a documented history of physical or mental illness, or drug abuse
- Infants from non-French -speaking families.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CH Albi
Albi, Midi-Pyrénées, 81013
CH Auch
Auch, Midi-Pyrénées, 32008
CH Cahors
Cahors, Midi-Pyrénées, 46005
CH Castres
Castres, Midi-Pyrénées, 81108
CHIVA centre hospitalier du val d'Ariège
Foix, Midi-Pyrénées, 09017
CH Montauban
Montauban, Midi-Pyrénées, 82013
CH Tarbes
Tarbes, Midi-Pyrénées, 65013
Hôpital des enfants
Toulouse, Midi-Pyrénées, 30159
Clinique Sarrus Teinturiers
Toulouse, Midi-Pyrénées, 31076
Clinique Ambroise Paré
Toulouse, Midi-Pyrénées, 31082
About this study
Official title: Early Post Hospital Discharge Psychomotor Therapy Intervention Program: Effect on the Development in Very Preterm Infants at 2-years Corrected Age
Our current reflexion is that sensory dys-stimulations, including vestibule-proprioceptive disorders and unbalanced between brain and brainstem maturation of the neonatal period involve an early deviant development for immature infants that will be cascaded through the brain scaffolding and later development. The primary purpose is to determine whether the Early Psychomotor Therapy Intervention Program improves development and behavior in very preterm infants (VPI) at 24-month corrected age (CA).
Read the detailed description
VPI < 30 week of amenorrhea were randomized, in a simple blind controlled trial. The psychomotor development was evaluated according to the Bayley Scales of Infant Development-III (BSID-III) at 2 years CA. An intermediate point was provided at 9 months CA. Pediatric standardized assessments and psychologist semi-directive interviews were conducted. Parents also completed a self-administering questionnaire relating to the post-traumatic stress. The intervention consisted on 20 therapy sessions between 2 and 9 months CA, in order to support infants' development, and parent-infant interactions and adjustment.
Extended description of the protocol, including more technical information (as compared to the Brief Summary) if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures.
- Conditions
- Premature Infant
- Being tested
- Early post hospital discharge psychomotor therapy
- Keywords
- Neuromotor sequelae, Cognitive disorders, Cerebral development, Psychomotoricity, Postural management, Motor coordination, Parenthood
- Medical subject headings
- Premature Birth, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early post hospital discharge psychomotor therapyOther
The intervention consisted on 20 psychomotor therapy sessions between 2 and 9 months, in order to support infants' development, and parent-infant interactions and adjustment. The therapy was based on body and emotional positive feelings and experiences, leading to improve sensory motor and perceptive integration, interactive and exploratory behaviors, physiological and tonic-emotional self-regulation, motor organization and early coordination. The intervention was a partnership with the parents, leading to decode the baby needs and expectations, for the parents to experiment more positive feelings, to become more confident in their own skills and more sensitive, and in synchrony with their baby. Intervention was supported by a detailed assessment scale implemented in the regional network related to the follow-up for vulnerable babies.
| Study group | Role | What they receive |
|---|---|---|
| Psychomotor therapy | Experimental | Early post hospital discharge psychomotor therapy. Receives: Other: Early post hospital discharge psychomotor therapy |
| Control | No intervention | No specific support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychomotor development assessment.
Assessed by the Bayley Scale Third Edition BSID-III.
Measured: Year 2
Secondary outcomes (3)
The acceptability of the protocol by the parents for the intervention group.
Assessed by a self-questionnaire given by the neonatologist at the end of the treatment.
Measured: Month 9
The quality of parenting.
Assessed by a grid (established by the team of child psychiatry neonatology).
Measured: Month 9; Year 2
The clinical evolution of the child assessed by a standardized neurological examination.
Assessed during the consultations planned in the network (neonatologists of the CHU), based on a standardized neurological examination.
Measured: Months 3, 6, 9, 12, 18, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start1 Dec 2007
- Primary completion1 Dec 2013
- Study completion8 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Premature InfantStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corinne Alberge, MD, Principal investigator, Hôpital des enfants, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093337
- Sponsor's protocol ID
- 07 227 01
- Other IDs
- 2007-A00997-46
- Acronym
- VPI
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2017
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jacobsson B, Hagberg G. Antenatal risk factors for cerebral palsy. Best Pract Res Clin Obstet Gynaecol. 2004 Jun;18(3):425-36. doi: 10.1016/j.bpobgyn.2004.02.011.
PubMed 15183137Palisano R, Rosenbaum P, Walter S, Russell D, Wood E, Galuppi B. Development and reliability of a system to classify gross motor function in children with cerebral palsy. Dev Med Child Neurol. 1997 Apr;39(4):214-23. doi: 10.1111/j.1469-8749.1997.tb07414.x.
PubMed 9183258Weisglas-Kuperus N, Koot HM, Baerts W, Fetter WP, Sauer PJ. Behaviour problems of very low-birthweight children. Dev Med Child Neurol. 1993 May;35(5):406-16.
PubMed 7684346Alberge C, Ehlinger V, Noack N, Bolzoni C, Colombie B, Breinig S, Dicky O, Delobel M, Arnaud C. Early psychomotor therapy in very preterm infants does not improve Bayley-III scales at 2 years. Acta Paediatr. 2023 Sep;112(9):1916-1925. doi: 10.1111/apa.16848. Epub 2023 Jun 5.
PubMed 37191836
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Post Hospital Discharge Psychomotor Therapy Intervention Program: Effect on the Development in Very Preterm Infants at 2-years Corrected Age
- ClinicalTrials.gov ID
- NCT03093337
- Acronym / sponsor ID
- VPI / 07 227 01
- Conditions
- Premature Infant
- Keywords
- Neuromotor sequelae, Cognitive disorders, Cerebral development, Psychomotoricity, Postural management, Motor coordination, Parenthood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Dec 2007 (actual)
- Primary completion
- 1 Dec 2013 (actual)
- Study completion
- 8 Jul 2017 (actual)
- First posted
- 28 Mar 2017 (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.
Our current reflexion is that sensory dys-stimulations, including vestibule-proprioceptive disorders and unbalanced between brain and brainstem maturation of the neonatal period involve an early deviant development for immature infants that will be cascaded through the brain scaffolding and later development. The primary purpose is to determine whether the Early Psychomotor Therapy Intervention Program improves development and behavior in very preterm infants (VPI) at 24-month corrected age (CA).
Detailed description
VPI < 30 week of amenorrhea were randomized, in a simple blind controlled trial. The psychomotor development was evaluated according to the Bayley Scales of Infant Development-III (BSID-III) at 2 years CA. An intermediate point was provided at 9 months CA. Pediatric standardized assessments and psychologist semi-directive interviews were conducted. Parents also completed a self-administering questionnaire relating to the post-traumatic stress. The intervention consisted on 20 therapy sessions between 2 and 9 months CA, in order to support infants' development, and parent-infant interactions and adjustment.
Extended description of the protocol, including more technical information (as compared to the Brief Summary) if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychomotor therapy | Experimental | Other: Early post hospital discharge psychomotor therapyEarly post hospital discharge psychomotor therapy. |
| Control | No intervention | –No specific support. |
Who may qualify
- Ages
- 24 to 30 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants with a gestational age between 24 and 30 weeks.
Key exclusion criteria (5 listed)
- Infants with congenital disease,
- Infants with brain bleeding grade III-IV,
- Infants with periventricular leucomalacia,
- Infants whose mothers had a documented history of physical or mental illness, or drug abuse
- Infants from non-French -speaking families.
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 |
|---|---|---|
| Early post hospital discharge psychomotor therapyThe intervention consisted on 20 psychomotor therapy sessions between 2 and 9 months, in order to support infants' development, and parent-infant interactions and adjustment. The therapy was based on body and emotional positive feelings and experiences, leading to improve sensory motor and perceptive integration, interactive and exploratory behaviors, physiological and tonic-emotional self-regulation, motor organization and early coordination. The intervention was a partnership with the parents, leading to decode the baby needs and expectations, for the parents to experiment more positive feelings, to become more confident in their own skills and more sensitive, and in synchrony with their baby. Intervention was supported by a detailed assessment scale implemented in the regional network related to the follow-up for vulnerable babies. | Other | Psychomotor therapy |
Primary outcome
Psychomotor development assessment.
Time frame: Year 2
Assessed by the Bayley Scale Third Edition BSID-III.
3 secondary outcomes
The acceptability of the protocol by the parents for the intervention group.
Time frame: Month 9
The quality of parenting.
Time frame: Month 9; Year 2
The clinical evolution of the child assessed by a standardized neurological examination.
Time frame: Months 3, 6, 9, 12, 18, 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Background: PubMed 15183137Jacobsson B, Hagberg G. Antenatal risk factors for cerebral palsy. Best Pract Res Clin Obstet Gynaecol. 2004 Jun;18(3):425-36. doi: 10.1016/j.bpobgyn.2004.02.011.
- Background: PubMed 9183258Palisano R, Rosenbaum P, Walter S, Russell D, Wood E, Galuppi B. Development and reliability of a system to classify gross motor function in children with cerebral palsy. Dev Med Child Neurol. 1997 Apr;39(4):214-23. doi: 10.1111/j.1469-8749.1997.tb07414.x.
- Background: PubMed 7684346Weisglas-Kuperus N, Koot HM, Baerts W, Fetter WP, Sauer PJ. Behaviour problems of very low-birthweight children. Dev Med Child Neurol. 1993 May;35(5):406-16.
- Results publication: PubMed 37191836Alberge C, Ehlinger V, Noack N, Bolzoni C, Colombie B, Breinig S, Dicky O, Delobel M, Arnaud C. Early psychomotor therapy in very preterm infants does not improve Bayley-III scales at 2 years. Acta Paediatr. 2023 Sep;112(9):1916-1925. doi: 10.1111/apa.16848. Epub 2023 Jun 5.
- Individual participant dataSharing planned: No
Related trials for Premature Infant
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
RecruitingObservational study
Motor Development and Early Predictors of Psychomotor Outcomes in Preterm and Term Infants Assessed by MOS-R and Caregiver Questionnaire at 18 and 36 Months
Neurodevelopmental Disorders, Motor Skills Disorders
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
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. This study is not recruiting at the moment.
Corinne Alberge, MD principal investigator
Hôpital des enfants, Toulouse
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early post hospital discharge psychomotor therapy in people with Premature Infant, run by University Hospital, Toulouse at 10 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychomotor development assessment. (time frame: Year 2). 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 NCT03093337, which also lists 4 linked publications.
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 6 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.