Very Premature BabyPIVOTNCT07903766
Effects of a Multisensory Intervention Program on the Term Behavior of the Very Premature Baby
A study testing Multisensory intervention program in people with Very Premature Baby, run by Assistance Publique Hopitaux De Marseille.
Trial summary
The growth and organization of the cerebral cortex is ensured by the oligodendrocyte-rich subplate, whose proper development depends on both subcortical structures and sensory experiences. Read more about this study
- Who is it for?
- Ages Up to 2 months
- Conditions the study is for
- Very Premature Baby
- What is being tested?
- Multisensory intervention program
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Feb 2030
- 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 Up to 2 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- premature babies whose term of birth is between 24 and 32 weeks of amenorrhea + 6 days, and whose corrected age is between 30 and 34 weeks of amenorrhea. at the time of inclusion
- free of neurological pathology rendering them clinically unstable, except for Papille grade 1 or 2 intraventricular hemorrhage on transfontanellar ultrasound or type 1 to 4 brain abnormalities on MRI according to the modified Paneth classification
- with a central venous output of less than 90 cc/kg/d
- free of infectious pathology making them clinically unstable (C-reactive protein less than 7)
- non-intubated
- respiratory stability at the start of CPAP weaning (at least 3 hours of room air in the last 48 hours: apnea and/or desaturation without stimulation required) or under high-flow glasses
- no genetic syndrome, progressive neurological disease or malformation
- whose 2 parents or legal guardians have agreed to participate and signed an informed consent form
Who cannot join
- premature babies born at less than 24 weeks of amenorrhea and more than 32 weeks of amenorrhea + 6 days, or newborns whose corrected age is greater than 34 weeks of amenorrhea
- with intraventricular hemorrhage grade 3 to 4 and/or MRI abnormality type 5 to 6 according to the modified Paneth classification
- presenting a nosocomial infection
- presenting cardio respiratory instability: continuous CPAP and intubation.
- presenting a surgical digestive pathology or ulcerative enteritis
- presenting a genetic syndrome, progressive neurological disease, malformative pathology or cleft lip and palate.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of a Multisensory Intervention Program Involving the Parents, From the Incubator Period, on the Term Behavior of the Very Premature Baby Born Between 24 and 32 Weeks of Amenorrhea Assessed by the NICU Network Neurobehavioral Scale (NNNS).
The growth and organization of the cerebral cortex is ensured by the oligodendrocyte-rich subplate, whose proper development depends on both subcortical structures and sensory experiences. In the incubator, the premature baby is exposed to inappropriate stimuli at a critical period of physiological immaturity and brain development. Analysis of the pathophysiological basis of neurological and behavioral disorders in premature infants highlights the interplay between biological vulnerability (cerebral alteration) and environmental factors (stress, perinatal pain and loss of emotional connection with the mother).
Developmental care aims to modify the environment in order to limit deviant developmental trajectories and reduce neurobehavioral impact, by relying on brain plasticity. This care consists of a set of environmental and behavioral strategies based on principles of balance between different stimuli adapted to cerebral maturation. The usefulness of multimodal sensory interventions as early as 28 weeks of amenorrhea has been demonstrated to offset the harmful effects of incubator dystimulation.
Read more
These interventions improve neurobehavioral disorders and reduce parental stress, but none has been shown to be superior. Welch's studies published in 2015 and 2017, based on the definition of emotional co-regulation processes, show the value of involving parents in care during hospitalization, from the incubator period onwards.
The hypothesis of this study is that multisensory intervention in a calming cycle can induce neurobehavioral improvement at term age in the very premature baby. The intervention consists of a parenting workshop and an incubator-based multisensory solicitation program with tactile, vestibular, visual and vocal contact performed by the mother or, where appropriate, the father, combined with the diffusion of maternal odor. The aim is to evaluate the effectiveness of this multisensory intervention on the behavior at term (in corrected age) of the very premature baby born between 24 and 32 weeks of amenorrhea.
- Conditions
- Very Premature Baby
- Being tested
- Multisensory intervention program, Standard care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multisensory intervention programOther
- Training workshop for parents (information on the sensory-motor needs of premature babies, viewing of a training video, training on a neonatal dummy)
- Multisensory incubator stimulation by the mother (or father, if applicable)
- Mother scent diffusion, tactile and vestibular stimulation
Gauze is placed in the mother's bra the night before each training session, and placed in a closed bag immediately after removal
Standard careOther
Skin-to-skin contact, oral-facial stimulation, breastfeeding etc...
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Standard care and multisensory training Receives: Other: Multisensory intervention program; Other: Standard care |
| Control group | Other | Standard care Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of preterm behavior using the NICU Network Neurobehavioral Scale (NNNS) neurobehavioral scale
The NNNS neurobehavioral scale comprises 13 dimensions: habituation (3 items rated between 1 and 9), orientation (7 items rated between 1 and 9), self-regulation (15 items rated between 1 and 9), hypertonia (10 items rated between 0 and 10), hypotonia (10 items rated between 0 and 10), asymmetry reflexes (16 items rated between 0 and 16), non-optimal reflexes (15 items rated between 0 and 15), excitability (15 items rated between 0 and 15), lethargy (15 items rated between 0 and 15), arousal (7 items rated between 1 and 9), quality of movement (6 items rated between 1 and 9), stress ( 50 items rated between 0 and 1) and handling tolerance (8 items rated between 0 and 1). This assessment is carried out at 37 weeks of amenorrhea by a trained pyschomotrician before the premature baby is discharged from hospital Higher scores reflect better neurobehavioral construction.
Measured: 37 weeks of amenorrhea before the premature baby is discharged from hospital
Secondary outcomes (11)
Average weight gain (g/kg/d)
Measured: Day -1, at Day 1 and Day 10, at discharge and at 3 months corrected age
Baby's tolerance of multi-sensory stimulation
Simplified NIDCAP grid evaluation (Tolerance)
Measured: days 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 of the multi-sensory stimulation
Total length of hospital stay
Number of days in hospital
Measured: At the time of hospital discharge (up to 6 months)
Duration of skin-to-skin contact per day from inclusion to incubator discharge
Hour(s)/day of skin-to-skin contact
Measured: during hospitalisation (up to 6 months) and at the time of hospitalisation discharge (up to 6 months)
Duration of breast-feeding
Number of days breastfeeding or bottle-feeding with breast milk
Measured: At the time of hospital discharge (up to 6 months) and at the medical consultation at 3 months of corrected age
Post-traumatic stress of mother and father
Parents will complete the Perinatal Posttraumatic stress disorder (PPQ) questionnaire
Measured: At the medical consultation at 3 months of corrected age
Mother's and father's anxiety levels
Anxiety symptoms will be assessed using the Spielberger scale : from a score of 20 (no anxiety) to a score of 80 (high anxiety)
Measured: At inclusion, at the baby's discharge from hospital (up to 6 months), and at the medical consultation at 3 months of corrected
Quality of life of mother and father
Quality of life will be assessed using the questionnaire (SF 36)
Measured: At the medical consultation at 3 months of corrected age
Spontaneous motricity
Spontaneous motricity will be assessed using the Prechtl technique via video recording
Measured: At the medical consultation between 3 and 4 months of corrected age
Staturo-ponderal growth
Measured: During hospitalization (up to 6 months) and at the time of hospitalisation discharge (up to 6 months), then at the medical consultation at 3 months of corrected age
Parent-child interaction
Interactive Behavior coding will be carried out during breastfeeding or bottle-feeding, using a video recording
Measured: At the medical consultation at 3 months 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 posted29 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionFeb 2030 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Very Premature BabyStudies of the same condition, open and under way.
- 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
- Sequential
- Model description
- Stepped-wedge
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine GIRE, Principal investigator, Assistance Publique - Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903766
- Sponsor's protocol ID
- RCAPHM21_0411
- Acronym
- PIVOT
- Status last verified
- Oct 2026
- First submitted
- 15 Apr 2024
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Multisensory Intervention Program Involving the Parents, From the Incubator Period, on the Term Behavior of the Very Premature Baby Born Between 24 and 32 Weeks of Amenorrhea Assessed by the NICU Network Neurobehavioral Scale (NNNS).
- ClinicalTrials.gov ID
- NCT07903766
- Acronym / sponsor ID
- PIVOT / RCAPHM21_0411
- Conditions
- Very Premature Baby
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 29 Oct 2026 (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 growth and organization of the cerebral cortex is ensured by the oligodendrocyte-rich subplate, whose proper development depends on both subcortical structures and sensory experiences. In the incubator, the premature baby is exposed to inappropriate stimuli at a critical period of physiological immaturity and brain development. Analysis of the pathophysiological basis of neurological and behavioral disorders in premature infants highlights the interplay between biological vulnerability (cerebral alteration) and environmental factors (stress, perinatal pain and loss of emotional connection with the mother).
Developmental care aims to modify the environment in order to limit deviant developmental trajectories and reduce neurobehavioral impact, by relying on brain plasticity. This care consists of a set of environmental and behavioral strategies based on principles of balance between different stimuli adapted to cerebral maturation. The usefulness of multimodal sensory interventions as early as 28 weeks of amenorrhea has been demonstrated to offset the harmful effects of incubator dystimulation.
These interventions improve neurobehavioral disorders and reduce parental stress, but none has been shown to be superior. Welch's studies published in 2015 and 2017, based on the definition of emotional co-regulation processes, show the value of involving parents in care during hospitalization, from the incubator period onwards.
The hypothesis of this study is that multisensory intervention in a calming cycle can induce neurobehavioral improvement at term age in the very premature baby. The intervention consists of a parenting workshop and an incubator-based multisensory solicitation program with tactile, vestibular, visual and vocal contact performed by the mother or, where appropriate, the father, combined with the diffusion of maternal odor. The aim is to evaluate the effectiveness of this multisensory intervention on the behavior at term (in corrected age) of the very premature baby born between 24 and 32 weeks of amenorrhea.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-wedge
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Multisensory intervention program, Other: Standard careStandard care and multisensory training |
| Control group | Other | Other: Standard careStandard care |
Who may qualify
- Ages
- Up to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- premature babies whose term of birth is between 24 and 32 weeks of amenorrhea + 6 days, and whose corrected age is between 30 and 34 weeks of amenorrhea. at the time of inclusion
- free of neurological pathology rendering them clinically unstable, except for Papille grade 1 or 2 intraventricular hemorrhage on transfontanellar ultrasound or type 1 to 4 brain abnormalities on MRI according to the modified Paneth classification
- with a central venous output of less than 90 cc/kg/d
- free of infectious pathology making them clinically unstable (C-reactive protein less than 7)
- non-intubated
Key exclusion criteria (6 listed)
- premature babies born at less than 24 weeks of amenorrhea and more than 32 weeks of amenorrhea + 6 days, or newborns whose corrected age is greater than 34 weeks of amenorrhea
- with intraventricular hemorrhage grade 3 to 4 and/or MRI abnormality type 5 to 6 according to the modified Paneth classification
- presenting a nosocomial infection
- presenting cardio respiratory instability: continuous CPAP and intubation.
- presenting a surgical digestive pathology or ulcerative enteritis
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 |
|---|---|---|
| Multisensory intervention program* Training workshop for parents (information on the sensory-motor needs of premature babies, viewing of a training video, training on a neonatal dummy) * Multisensory incubator stimulation by the mother (or father, if applicable) * Mother scent diffusion, tactile and vestibular stimulation Gauze is placed in the mother's bra the night before each training session, and placed in a closed bag immediately after removal | Other | Experimental group |
| Standard careSkin-to-skin contact, oral-facial stimulation, breastfeeding etc... | Other | Control group, Experimental group |
Primary outcome
Assessment of preterm behavior using the NICU Network Neurobehavioral Scale (NNNS) neurobehavioral scale
Time frame: 37 weeks of amenorrhea before the premature baby is discharged from hospital
The NNNS neurobehavioral scale comprises 13 dimensions: habituation (3 items rated between 1 and 9), orientation (7 items rated between 1 and 9), self-regulation (15 items rated between 1 and 9), hypertonia (10 items rated between 0 and 10), hypotonia (10 items rated between 0 and 10), asymmetry reflexes (16 items rated between 0 and 16), non-optimal reflexes (15 items rated between 0 and 15), excitability (15 items rated between 0 and 15), lethargy (15 items rated between 0 and 15), arousal (7 items rated between 1 and 9), quality of movement (6 items rated between 1 and 9), stress ( 50 items rated between 0 and 1) and handling tolerance (8 items rated between 0 and 1). This assessment is carried out at 37 weeks of amenorrhea by a trained pyschomotrician before the premature baby is discharged from hospital Higher scores reflect better neurobehavioral construction.
11 secondary outcomes
Average weight gain (g/kg/d)
Time frame: Day -1, at Day 1 and Day 10, at discharge and at 3 months corrected age
Baby's tolerance of multi-sensory stimulation
Time frame: days 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 of the multi-sensory stimulation
Total length of hospital stay
Time frame: At the time of hospital discharge (up to 6 months)
Duration of skin-to-skin contact per day from inclusion to incubator discharge
Time frame: during hospitalisation (up to 6 months) and at the time of hospitalisation discharge (up to 6 months)
Duration of breast-feeding
Time frame: At the time of hospital discharge (up to 6 months) and at the medical consultation at 3 months of corrected age
Post-traumatic stress of mother and father
Time frame: At the medical consultation at 3 months of corrected age
Mother's and father's anxiety levels
Time frame: At inclusion, at the baby's discharge from hospital (up to 6 months), and at the medical consultation at 3 months of corrected
Quality of life of mother and father
Time frame: At the medical consultation at 3 months of corrected age
Spontaneous motricity
Time frame: At the medical consultation between 3 and 4 months of corrected age
Staturo-ponderal growth
Time frame: During hospitalization (up to 6 months) and at the time of hospitalisation discharge (up to 6 months), then at the medical consultation at 3 months of corrected age
Parent-child interaction
Time frame: At the medical consultation at 3 months 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 29 Oct 2026.
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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.
Catherine GIRE principal investigator
Assistance Publique - Hôpitaux de Marseille
Questions about this trial
What is this clinical trial studying?
A study testing Multisensory intervention program in people with Very Premature Baby, run by Assistance Publique Hopitaux De Marseille.
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 8 inclusion and 6 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: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Pascale CLOQUELL (0491968300, pascale.cloquell@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of preterm behavior using the NICU Network Neurobehavioral Scale (NNNS) neurobehavioral scale (time frame: 37 weeks of amenorrhea before the premature baby is discharged from hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2026.