Cerebral PalsyIA-NPINCT01779661
Infant Aquatics Neurodevelopment Premature Infants
A study testing Infant Aquatics and Infant Massage in people with Cerebral Palsy and Preterm Birth, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The objective of this research is to examine the effect of Infant Aquatics on the development of and neurodevelopment of preterm and near-term infants, using the GM as prognostic estimation of future development. Read more about this study
- Who is it for?
- Ages 1 week to 4 weeksHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Preterm Birth, Development
- What is being tested?
- Infant Aquatics and Infant Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2013to Aug 2015
- 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 1 week to 4 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Major inclusion criteria: Infants who are hemodynamic stable, no seizures or apnea attacks, IVH/PVH grade < 3, without diagnoses of chromosomal abnormalities, infants whose parents want to cooperate, will be included. These criteria follow our aim to include vulnerable groups of infants for which research results may dramatically promote development.
Who cannot join
- infants whose parents are not able to understand research goals and refuse to cooperate, infants with seizures or apnea attacks, IVH/PVH grade >or =3, with diagnoses of chromosomal abnormalities.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Chaim Seba Medical Center
Ramat Gan, 56210
Omer Bar-Yosef, MD PhD, omerbary@gmail.com
Caroline Barmatz, HT BPT MHA, caroline.barmatz@gmail.com]
About this study
Official title: The Effect of Infant Aquatics for Neurodevelopment of Premature Infants
The objective of this research is to examine the effect of Infant Aquatics on the development of and neurodevelopment of preterm and near-term infants, using the GM as prognostic estimation of future development.
Preterm infants, a continuously growing population, are at high risk for neurodevelopment impairments ranging from minor neurological dysfunction (MND) to cerebral palsy (CP), mainly due to developmental brain injury. Infant Aquatics have been found to benefit and promote infant development. The support and sensory stimulation of the water may improve the development the sensory, motor, as well as, autonomic system of preterm infants.
The study will compare intervention by Infant Aquatics to infant massage. The intervention in both methods will start at 36 weeks gestational age for 3 months and will consist of sessions with a therapist every 2 weeks. Development will be assessed and compared at 3, 8 and 18 months using Infant Motor Pattern method, Griffith developmental scales and Vineland adaptive behavior scales.
- Conditions
- Cerebral Palsy, Preterm Birth, Development
- Being tested
- Infant Aquatics, Infant Massage
- Keywords
- Neurodevelopment, Infant-Aquatics, Prematurity
- Medical subject headings
- Cerebral Palsy, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant AquaticsOther
Infant Aquatics in this study is composed of a set of pre-structured movements and techniques of relaxation, through harmonic integration of various approaches, each having a role in a specific time-window or in the infant's developmental sequence along study interventional timeline
Infant MassageOther
Infant Massage
| Study group | Role | What they receive |
|---|---|---|
| Infant Aquatics | Active comparator | Not described Receives: Other: Infant Aquatics |
| Infant Massage | Active comparator | Infant Massage Receives: Other: Infant Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Developmental assessment - a composite of several measures
Developmental assessment at term and three month
- General Movements Neuromotor scale
- Neurological examination
Measured: 3 month
Secondary outcomes (1)
Developmental assessment - a composite of several measures
Developmental assessment at 18 month
- IMP neuromotor developmental scale
- Griffith mental development scale
- Vineland adaptive behavior scale
Measured: 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startApr 2013
- Primary completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- University of Haifa
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779661
- Sponsor's protocol ID
- SHEBA-12-9524-OB-CTIL
- Acronym
- IA-NPI
- Status last verified
- Feb 2014
- First submitted
- 27 Jan 2013
- Last updated
- 13 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Infant Aquatics for Neurodevelopment of Premature Infants
- ClinicalTrials.gov ID
- NCT01779661
- Acronym / sponsor ID
- IA-NPI / SHEBA-12-9524-OB-CTIL
- Conditions
- Cerebral Palsy, Preterm Birth, Development
- Keywords
- Neurodevelopment, Infant-Aquatics, Prematurity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- University of Haifa
- Study start
- Apr 2013
- Primary completion
- Aug 2015 (estimated)
- First posted
- 30 Jan 2013 (estimated)
- 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 objective of this research is to examine the effect of Infant Aquatics on the development of and neurodevelopment of preterm and near-term infants, using the GM as prognostic estimation of future development.
Preterm infants, a continuously growing population, are at high risk for neurodevelopment impairments ranging from minor neurological dysfunction (MND) to cerebral palsy (CP), mainly due to developmental brain injury. Infant Aquatics have been found to benefit and promote infant development. The support and sensory stimulation of the water may improve the development the sensory, motor, as well as, autonomic system of preterm infants.
The study will compare intervention by Infant Aquatics to infant massage. The intervention in both methods will start at 36 weeks gestational age for 3 months and will consist of sessions with a therapist every 2 weeks. Development will be assessed and compared at 3, 8 and 18 months using Infant Motor Pattern method, Griffith developmental scales and Vineland adaptive behavior scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infant Aquatics | Active comparator | Other: Infant Aquatics |
| Infant Massage | Active comparator | Other: Infant MassageInfant Massage |
Who may qualify
- Ages
- 1 week to 4 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Major inclusion criteria: Infants who are hemodynamic stable, no seizures or apnea attacks, IVH/PVH grade < 3, without diagnoses of chromosomal abnormalities, infants whose parents want to cooperate, will be included. These criteria follow our aim to include vulnerable groups of infants for which research results may dramatically promote development.
Key exclusion criteria (1 listed)
- infants whose parents are not able to understand research goals and refuse to cooperate, infants with seizures or apnea attacks, IVH/PVH grade >or =3, with diagnoses of chromosomal abnormalities.
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 |
|---|---|---|
| Infant AquaticsInfant Aquatics in this study is composed of a set of pre-structured movements and techniques of relaxation, through harmonic integration of various approaches, each having a role in a specific time-window or in the infant's developmental sequence along study interventional timeline | Other | Infant Aquatics |
| Infant MassageInfant Massage | Other | Infant Massage |
Primary outcome
Developmental assessment - a composite of several measures
Time frame: 3 month
Developmental assessment at term and three month 1. General Movements Neuromotor scale 2. Neurological examination
1 secondary outcome
Developmental assessment - a composite of several measures
Time frame: 18 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2014.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant Aquatics and Infant Massage in people with Cerebral Palsy and Preterm Birth, run by Sheba Medical Center at 1 site in Israel.
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 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: status not confirmed, as of the sponsor's last update on 13 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hagit Friedman, PhD (972-54-5841314, hmts@netvision.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Developmental assessment - a composite of several measures (time frame: 3 month). 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 13 Feb 2014.