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AzTrials

OsteopathyNCT06967870

The Effect of Cranial Osteopathy Intervention in Preterm Babies

A study testing Osteopathic intervention and Home based exercise education in people with Osteopathy and PreTerm Neonate, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

There are planing to have 2 groups of premature born cases. Each group will include 15 cases. Participants are need to be 28-37 weeks born and no older than post term 6 weeks. All cases are going to be evaluated. Home based exercise plan is going to be explained. Read more about this study

Who is it for?
Ages 1 week to 6 weeksHealthy volunteers can take part
Conditions the study is for
Osteopathy, PreTerm Neonate, Sensory Profiles
What is being tested?
Osteopathic intervention and Home based exercise education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
5 May 2025to 8 Oct 2025
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 1 week to 6 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Premature birth (<37 weeks)
  • Corrected age <6 weeks.
  • Discharged to home
  • Stable condition
  • Family agrees to continue home program

Who cannot join

  • Having a congenital cyanotic heart problem,
  • Being born earlier than 28 weeks,
  • The family not accepting to participate in the study,
  • Neglecting check-ups and sessions,
  • Using a respiratory appliance,
  • Presence of craniosynostosis,
  • Being included in another physiotherapy program during the study period

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Eylem Tütün Yümin, Professor contact

00905056763191

tutun_e@ibu.edu.tr

Turkey (Türkiye)1 site
  • Bahriye Baş

    Bursa, Osmangazi, 16165

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Cranial Osteopathy Intervention on Sensory Profile, Sleep Quality, Colic Symptoms and Motor Movements in Preterm Babies

There are planing to have 2 groups of premature born cases. Each group will include 15 cases. Participants are need to be 28-37 weeks born and no older than post term 6 weeks. All cases are going to be evaluated. Home based exercise plan is going to be explained. The experimental group is going to take 6 osteopathic sessions weekly. After 6 weeks cases are going to be evaluated again.

Read the detailed description

Babies born at or before the 37th week of pregnancy are defined as preterm babies. While the number of premature babies has increased in recent years, the survival rates of preterm babies have also increased with the development of neonatal intensive care units. Neurodevelopmental problems can be seen at a higher rate in premature babies compared to term babies. In preterm births, birth occurs at critical stages of brain and nervous system development in the baby. It has been stated in the literature that even late preterm babies may experience problems in sensory processing and regulation stages. The addition of factors such as neonatal intensive care history to preterm birth causes them to score even lower in terms of sensory profile compared to term babies. It has been stated that preterm babies are in the high-risk group in terms of sensory processing problems. In a systematic review conducted in 2019, it was stated that premature babies and children have sensory modulation problems at a rate of 28-87%; sensory processing problems at a rate of 9-70%, and sensory-based motor processing problems at a rate of 20-70%.

Colic in babies; It is a condition characterized by sudden, persistent and restless crying in a generally healthy situation. Abdominal bloating and irritability often accompany the crying. It is difficult for the baby to calm down and fall asleep.Although the etiopathogenesis of colic in the neonatal period has not been fully determined, it has been stated that the underdeveloped nervous system, gastrointestinal system and stress factors are triggers. Studies have shown that the frequency of colic increases as the baby's gestational age decreases.

Sleep is the primary activity of the developing brain in early life, so it is not surprising that sleep plays a very important role in brain development. The existence of a sleep-wake cycle, sleep architecture and the percentage of the 24-hour period spent sleeping in the neonatal period have been associated with neurodevelopmental outcomes.

The importance of early intervention in preterm babies is emphasized in the literature. Although there are no protocol-determined intervention methods for babies in the developmental risk group, it has been recommended to start developmental intervention as early as possible. Osteopathic manual therapy applications consist of drug-free, non-invasive, and manually applied methods. They are important methods used to contribute to the health of babies. The focus is on tissue tensions that occur especially in the cranial regions of babies. There are a limited number of studies in the literature on the effectiveness of cranial osteopathic applications. No study has been found on the effect of cranial osteopathy on the sensory profile of the baby. Although there are studies evaluating the relationship between the baby's sleep quality and colic symptoms, different results have been obtained. This study was planned to contribute to the literature by investigating the effect of cranial osteopathy on the sensory profile, sleep quality and colic symptoms in premature babies. In the study, in addition to obtaining evidence-based data on cranial osteopathic applications, it was aimed to examine the effects on the sensory profile, sleep quality, colic symptoms and motor performance of preterm babies.

Being tested
Osteopathic intervention, Home based exercise education
Keywords
manual therapy, premature, sensory integration, early intervention, cranial
Medical subject headings
Colic, Sleep Initiation and Maintenance Disorders, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Osteopathic interventionOther

    Researcher will use osteopathic techniques on cranial area includes light touch.

    Home based exercises will be show on cases and demand to do exercise regularly

  • Home based exercise educationOther

    Home based exercises will be show on cases and demand to do exercise regularly.

Study groups in NCT06967870
Study groupRoleWhat they receive
Osteopathy intervention groupExperimentalBeginning of the project assesment will be made, home exercises are going to be explained and said to continue exercises every day. Cases in this group will take 6 osteopathy sessions weekly. After 6 weeks assesment will be made again.
Receives: Other: Osteopathic intervention; Other: Home based exercise education
Home based exercises groupActive comparatorBeginning of the project assesment will be made, home exercises are going to be explained and said to continue exercises every day. After 6 weeks assesment will be made again.
Receives: Other: Home based exercise education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Test of Infant Motor Performance

    The test is a motor outcome measure designed to assess posture and selective control of movement in infants for functional performance in daily life. The test consists of 31 items in standard format, 28 of which are made by observing spontaneous activities and scoring them as pass or fail. Getting higher points means better motor control.

    Measured: 6 weeks

Secondary outcomes (3)
  1. Assessment of General Movements

    This is a diagnostic tool for the functional assessment of the young nervous system. General Movements is a diagnostic tool based on visual gestalt perception of videoed agespecific normal or abnormal general movements. Motor Optimality Scores < = 23 at 14-16 weeks of corrected age are predictive of motor, cognitive, and neurosensory motor impairment, and scores <=15 are predictive of CP.

    Measured: 6 weeks

  2. The Infant Colic Scale

    This Scale was developed to help diagnose colic. The scale has a total of 22 items in 5 subscales. Cow's milk/soy protein allergy/intolerance, immature gastrointestinal system, immature central nervous system, difficult baby temperament, parent-baby interaction-problem baby. Infant colic scale items are evaluated over 6 points. Likert-type scale is used. Low score is an indicator of colic

    Measured: 6 weeks

  3. Brief Infant Sleep Questionnaire

    It is a questionnaire that provides objective measurement of infant sleep. It has 13 items. It is an assessment form regarding sleep patterns, sleep ecology and parents' sleep perceptions of babies aged 0-36 months. The questionnaire includes specific items about the baby's day and night sleep patterns as well as sleep-related behaviors and parental perception.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2025
  2. Study start5 May 2025 (estimated)
  3. Primary completion28 Aug 2025 (estimated)
  4. Study completion8 Oct 2025 (estimated)

Resources

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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06967870
Sponsor's protocol ID
AIBU-FTR-ETY-04
Status last verified
May 2025
First submitted
3 Mar 2025
Last updated
13 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Osteopathic intervention and Home based exercise education in people with Osteopathy and PreTerm Neonate, run by Abant Izzet Baysal 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 5 inclusion and 7 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 13 May 2025. 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?

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 Eylem Tütün Yümin, Professor (00905056763191, tutun_e@ibu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Test of Infant Motor Performance (time frame: 6 weeks). 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 May 2025.

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