NCT06967870

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

May 5, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 13, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2025

Completed
Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

4 months

First QC Date

March 3, 2025

Last Update Submit

May 5, 2025

Conditions

OsteopathyPreTerm NeonateSensory ProfilesColicSleep QualityMotor Development of Premature Infants

Keywords

manual therapyprematuresensory integrationearly interventioncranial

Outcome Measures

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.

    6 weeks

Secondary Outcomes (3)

  • Assessment of General Movements

    6 weeks

  • The Infant Colic Scale

    6 weeks

  • Brief Infant Sleep Questionnaire

    6 weeks

Study Arms (2)

Osteopathy intervention group

EXPERIMENTAL

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 interventionOther: Home based exercise education

Home based exercises group

ACTIVE COMPARATOR

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

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

Osteopathy intervention group
Home based exercise educationOTHER

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

Home based exercises groupOsteopathy intervention group

Eligibility Criteria

Age1 Week - 6 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahriye Baş

Bursa, Osmangazi, 16165, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ColicSleep Initiation and Maintenance DisordersPremature Birth

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Eylem Tütün Yümin, Professor

CONTACT

00905056763191tutun_e@ibu.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 3, 2025

First Posted

May 13, 2025

Study Start

May 5, 2025

Primary Completion

August 28, 2025

Study Completion

October 8, 2025

Last Updated

May 13, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)