The Effect of Cranial Osteopathy Intervention in Preterm Babies

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-6
SponsorAbant Izzet Baysal University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Premature birth (<37 weeks)

Corrected age <6 weeks.

Discharged to home

Stable condition

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Osteopathic intervention

    Other 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

  • Home based exercise education

    Other intervention

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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Osteopathy intervention groupExperimental treatment 2 interventions
Group B: Home based exercises groupActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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