ClinicalTrials.gg
Not yet recruitingNCT06967870Updated May 13, 2025

The Effect of Cranial Osteopathy Intervention in Preterm Babies

An interventional study of Osteopathic intervention and Home based exercise education in Osteopathy, PreTerm Neonate and Sensory Profiles, sponsored by Abant Izzet Baysal University. Not yet recruiting at 1 site in Turkey. Open to participants aged 1 Week to 6 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-13.

Sponsored by Abant Izzet Baysal University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 2 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
1 Week to 6 Weeks
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Osteopathy
  • PreTerm Neonate
  • Sensory Profiles
  • Colic
  • Sleep Quality
  • Motor Development of Premature Infants

Keywords

  • manual therapy
  • premature
  • sensory integration
  • early intervention
  • cranial
03

In context

Colic

127 studies on the registry are indexed under Colic; 18 are open to participants now.

This study's planned enrollment of 30 is below the median of 76 across 110 interventional studies indexed under Colic.

Browse Colic studies →

Lead sponsor

Abant Izzet Baysal University is the lead sponsor of 250 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Week to 6 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Osteopathy intervention group

    Beginning 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.

    Other: Osteopathic intervention · Other: Home based exercise education

  • Active comparator
    Home based exercises group

    Beginning 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.

    Other: Home based exercise education

Interventions

  • OtherOsteopathic intervention

    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

  • OtherHome based exercise education

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

06

What researchers measure

Primary outcomes

  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.

    Time frame: 6 weeks

Secondary outcomes

  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.

    Time frame: 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

    Time frame: 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.

    Time frame: 6 weeks

07

Study locations

1 site
  • Bahriye Baş
    Bursa, Osmangazi 16165, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06967870
Responsible party
Eylem TÜTÜN YÜMİN (Professor, Abant Izzet Baysal University) — Principal investigator
First posted
May 13, 2025
Start date
May 5, 2025 (estimated)
Primary completion
Aug 28, 2025 (estimated)
Completion
Oct 8, 2025 (estimated)
Last update
May 13, 2025

Study contacts

Eylem Tütün Yümin, Professor
Contact
tutun_e@ibu.edu.tr
00905056763191

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion