Premature NeonateclownsNCT02048202
Medical Clowning in the NICU (Neonatal Intensive Care Unit and Their Effects on Parents and Staff
An observational study of Premature Neonate, run by The Baruch Padeh Medical Center, Poriya at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 4 weeks
- Conditions the study is for
- Premature Neonate
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2014to Jan 2016
- Phase
- Observational
- 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 Up to 4 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Premature neonates 32 weeks gestation
Who may be able to join
- neonates wherein their parents have expressed consent to participate in trail
- neonates with parents who are able to understand and fill in questioners
- neonates with no chromosomal deficiencies and no genetic deficiency
Who cannot join
- neonates with parents who are unable to understand and fill in questioners
- neonates with intraventricular bleeding IVH/PVH
- neonates with periventricular hemorrhage
- neonates with known chromosomal deficiencies or genetic deficiency
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
The Baruch Padeh Medical Center - Poria
Tiberias, 15208
Shay Barak, MD, 050-6267496, sbarak@poria.health.gov.il
Hagit Friedman, PhD, 050-5841317, hmts@netvision.net.il
About this study
Official title: Effects of Medical Clowning (Dream Doctors) on the Development of the Nervous System and the Relationship Between Preterm Premature Baby Parents and NICU Staff
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.
Read the detailed description
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.
- Conditions
- Premature Neonate
- Keywords
- clown, neonate, premature
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| premature neonate | premature neonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
◦Developmental assessment - a composite of several measures
Measured: ◦Time Frame: 3 month
Secondary outcomes (1)
Developmental assessment - a composite of several measures
Safety Issue?: No
Measured: ◦◦Time Frame: 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature NeonateStudies 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
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Baruch Padeh Medical Center, Poriya
- Sponsor type
- Other government
- Collaborators
- University of Haifa
- Responsible party
- Sponsor
- Investigators
- Shay Barak, MD, Principal investigator, The Baruch Padeh Medical Center - PoriaAmir Kushnir, MD, Study chair, The Baruch Padeh Medical Center - PoriaHagit Friedman, PhD, Principal investigator, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048202
- Sponsor's protocol ID
- 38-2013.CTIL
- Acronym
- clowns
- Status last verified
- Jan 2015
- First submitted
- 21 Jan 2014
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Medical Clowning (Dream Doctors) on the Development of the Nervous System and the Relationship Between Preterm Premature Baby Parents and NICU Staff
- ClinicalTrials.gov ID
- NCT02048202
- Acronym / sponsor ID
- clowns / 38-2013.CTIL
- Conditions
- Premature Neonate
- Keywords
- clown, neonate, premature
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Baruch Padeh Medical Center, PoriyaOther government
- Collaborators
- University of Haifa
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 29 Jan 2014 (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 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.
Detailed description
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.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| premature neonate | – | –premature neonate |
Who may qualify
- Ages
- Up to 4 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Premature neonates 32 weeks gestation
Key inclusion criteria (3 listed)
- neonates wherein their parents have expressed consent to participate in trail
- neonates with parents who are able to understand and fill in questioners
- neonates with no chromosomal deficiencies and no genetic deficiency
Key exclusion criteria (4 listed)
- neonates with parents who are unable to understand and fill in questioners
- neonates with intraventricular bleeding IVH/PVH
- neonates with periventricular hemorrhage
- neonates with known chromosomal deficiencies or genetic deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
◦Developmental assessment - a composite of several measures
Time frame: ◦Time Frame: 3 month
1 secondary outcome
Developmental assessment - a composite of several measures
Time frame: ◦◦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 5 May 2015.
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Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
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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.
Shay Barak, MD principal investigator
The Baruch Padeh Medical Center - Poria
Amir Kushnir, MD study chair
The Baruch Padeh Medical Center - Poria
Hagit Friedman, PhD principal investigator
University of Haifa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Neonate, run by The Baruch Padeh Medical Center, Poriya 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 3 inclusion and 4 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 5 May 2015. 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 Shay Barak, MD (050-6267496, sbarak@poria.health.gov.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: ◦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 5 May 2015.