Infant, PrematureNCT03146351
The Effects of Family Centered Intervention Program on Preterm Infants
A study testing Family based early intervention program (NDT-Bobath based) in people with Infant, Premature, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Infant born preterm have an increased risk of adverse long-term developmental outcomes.The risk associated with preterm birth increase as gestational age decreases, and vulnerability remains in moderate and early preterm (<34 weeks) and late preterm (>34 weeks). Read more about this study
- Who is it for?
- Ages 1 day to 6 months
- Conditions the study is for
- Infant, Premature
- What is being tested?
- Family based early intervention program (NDT-Bobath based)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2015to Jul 2016
- 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 day to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Born before 37 gestational weeks,
- Accepting to join the study
- Corrected age 6 months or less
Who cannot join
- Having high risk factors (e.g. grade 3 or more intraventricular hemorrhage, PVL, serious seizure)
- Born after 37 weeks
- Corrected age greater than 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi Universitesi, Saglik Bilimleri Fakultesi, Fizyoterapi ve Rehabilitasyon Bolumu
Ankara
About this study
Official title: The Effects of Family Centered Physiotherapy Program on Preterm Infants
Infant born preterm have an increased risk of adverse long-term developmental outcomes.The risk associated with preterm birth increase as gestational age decreases, and vulnerability remains in moderate and early preterm (<34 weeks) and late preterm (>34 weeks). There are many studies in the literature showed that the prevalence of developmental delay increases with premature birth. However, there is no study in the literature investigates effect of early intervention program motor performance in subgroups of preterm infants. Hence the aim of this study is to evaluate the differences in effects of early intervention program on motor development in early and moderate (<34 weeks) and late preterm infants.
Read the detailed description
Fifty-two preterm infants corrected age less than 6 months included in this study. They were separated by their birth weeks. Babies with gestational ages between 34-36 weeks and 6 days (including the given days) are categorized as late preterm, while those born before 34 weeks are grouped as moderate and early preterm. Each group contains 26 infants.
First, sociodemographic information and histories of babies are obtaining. Ages and contact information of the parents are recording. Prenatal and natal risk factors of the mothers are querying. Gestational ages and height, weight, and head circumferences of babies at birth are recording. Number of pregnancies, live births and abortions, type of delivery, multiple pregnancies for mothers as well as consanguinity between parents are asking.The Alberta Infant Motor Scale is using to evaluate spontaneous motor movements of the baby. After the detailed examination, intervention program set up for infants. Both groups receive 3 months family based intervention program.
After the intervention program, both groups re-examined.
- Conditions
- Infant, Premature
- Being tested
- Family based early intervention program (NDT-Bobath based)
- Keywords
- preterm, infant, physiotherapy
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family based early intervention program (NDT-Bobath based)Other
Family based early intervention program is NDT - Bobath based home program. Physiotherapist teaches principles of the treatment to infants' family. Family applies the program at home.
| Study group | Role | What they receive |
|---|---|---|
| Early and moderate preterm group | Experimental | Infants born before 34 weeks included in this group Receives: Other: Family based early intervention program (NDT-Bobath based) |
| Late preterm group | Experimental | Infants born between 34 and 37 weeks included in this group Receives: Other: Family based early intervention program (NDT-Bobath based) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor performance using the Alberta Infant Motor Scale
Alberta Infant Motor Scale is used to examine motor performance.
Measured: This study is planned to be completed within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study startSep 2015
- Primary completionMay 2016
- Study completionJul 2016
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 Infant, PrematureStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- non-randomised clinical trial
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Fatih KOCYIGIT, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146351
- Sponsor's protocol ID
- MURATKOCYİGİT
- Status last verified
- May 2017
- First submitted
- 19 Apr 2017
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We have no decided yet
Publications
Kyno NM, Ravn IH, Lindemann R, Fagerland MW, Smeby NA, Torgersen AM. Effect of an early intervention programme on development of moderate and late preterm infants at 36 months: a randomized controlled study. Infant Behav Dev. 2012 Dec;35(4):916-26. doi: 10.1016/j.infbeh.2012.09.004. Epub 2012 Oct 11.
PubMed 23063851
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Family Centered Physiotherapy Program on Preterm Infants
- ClinicalTrials.gov ID
- NCT03146351
- Acronym / sponsor ID
- MURATKOCYİGİT
- Conditions
- Infant, Premature
- Keywords
- preterm, infant, physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 9 May 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.
Infant born preterm have an increased risk of adverse long-term developmental outcomes.The risk associated with preterm birth increase as gestational age decreases, and vulnerability remains in moderate and early preterm (<34 weeks) and late preterm (>34 weeks). There are many studies in the literature showed that the prevalence of developmental delay increases with premature birth. However, there is no study in the literature investigates effect of early intervention program motor performance in subgroups of preterm infants. Hence the aim of this study is to evaluate the differences in effects of early intervention program on motor development in early and moderate (<34 weeks) and late preterm infants.
Detailed description
Fifty-two preterm infants corrected age less than 6 months included in this study. They were separated by their birth weeks. Babies with gestational ages between 34-36 weeks and 6 days (including the given days) are categorized as late preterm, while those born before 34 weeks are grouped as moderate and early preterm. Each group contains 26 infants.
First, sociodemographic information and histories of babies are obtaining. Ages and contact information of the parents are recording. Prenatal and natal risk factors of the mothers are querying. Gestational ages and height, weight, and head circumferences of babies at birth are recording. Number of pregnancies, live births and abortions, type of delivery, multiple pregnancies for mothers as well as consanguinity between parents are asking.The Alberta Infant Motor Scale is using to evaluate spontaneous motor movements of the baby. After the detailed examination, intervention program set up for infants. Both groups receive 3 months family based intervention program.
After the intervention program, both groups re-examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- non-randomised clinical trial
| Arm | Type | Receives |
|---|---|---|
| Early and moderate preterm group | Experimental | Other: Family based early intervention program (NDT-Bobath based)Infants born before 34 weeks included in this group |
| Late preterm group | Experimental | Other: Family based early intervention program (NDT-Bobath based)Infants born between 34 and 37 weeks included in this group |
Who may qualify
- Ages
- 1 day to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Born before 37 gestational weeks,
- Accepting to join the study
- Corrected age 6 months or less
Key exclusion criteria (3 listed)
- Having high risk factors (e.g. grade 3 or more intraventricular hemorrhage, PVL, serious seizure)
- Born after 37 weeks
- Corrected age greater than 6 months
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 |
|---|---|---|
| Family based early intervention program (NDT-Bobath based)Family based early intervention program is NDT - Bobath based home program. Physiotherapist teaches principles of the treatment to infants' family. Family applies the program at home. | Other | Early and moderate preterm group, Late preterm group |
Primary outcome
Motor performance using the Alberta Infant Motor Scale
Time frame: This study is planned to be completed within 6 months
Alberta Infant Motor Scale is used to examine motor performance.
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 9 May 2017.
- Background: PubMed 23063851Kyno NM, Ravn IH, Lindemann R, Fagerland MW, Smeby NA, Torgersen AM. Effect of an early intervention programme on development of moderate and late preterm infants at 36 months: a randomized controlled study. Infant Behav Dev. 2012 Dec;35(4):916-26. doi: 10.1016/j.infbeh.2012.09.004. Epub 2012 Oct 11.
- Individual participant dataSharing planned: Undecided. We have no decided yet
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family based early intervention program (NDT-Bobath based) in people with Infant, Premature, run by Gazi University at 1 site in Turkey (Türkiye).
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 3 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 9 May 2017. 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 Turkey (Türkiye). 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?
Motor performance using the Alberta Infant Motor Scale (time frame: This study is planned to be completed within 6 months). 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 NCT03146351, 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 9 May 2017.