Infants Admitted to Neonatal UnitsNCT07201792
Effects of Early Physiotherapy Program on the Infants in NICU
A study testing Early Physiotherapy in people with Infants Admitted to Neonatal Units and NICU, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
High-risk of Infants are defined as one with a history of negative environmental and biological factors that could lead to neuromotor developmental problems. This heterogeneous group encompasses premature babies born at less than 37 weeks, term babies with low birth weight (LBW), or babies with developmental delays… Read more about this study
- Who is it for?
- Ages 28 to 42 weeks
- Conditions the study is for
- Infants Admitted to Neonatal Units, NICU, NICU Infants
- What is being tested?
- Early Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2027to 30 Dec 2027
- 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 28 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns diagnosed with periventricular hemorrhage (PVH), intracranial hemorrhage (ICH), cystic PVL, HIE, kernicterus, perinatal asphyxia, neonatal sepsis, necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP), RDS, or BPD.
- Newborns receiving oxygen or mechanical ventilation (MV) support.
- Infants with a 5-minute Apgar score <3, <37 weeks' gestation, <1500 g preterm, or prematurity due to multiple births.
Who cannot join
- Newborns with congenital malformations (spina bifida, congenital muscular torticollis, arthrogryposis multiplex congenita, etc.), babies diagnosed with metabolic and genetic diseases (down syndrome, spinal muscular atrophy, duchenne muscular dystrophy, etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
hatice Adiguzel tat, Associate Proffessor contact
Turkey (Türkiye)1 site
Kahramanmaraş Sütçü imam University
Kahramanmaraş, Onikişubet, 46100
05056491048
About this study
Official title: Effects of Early Physiotherapy Program on the Infants in the Neonatal Intensive Care Unit: A Randomized Controlled Clinical Trial
High-risk of Infants are defined as one with a history of negative environmental and biological factors that could lead to neuromotor developmental problems. This heterogeneous group encompasses premature babies born at less than 37 weeks, term babies with low birth weight (LBW), or babies with developmental delays due to various causes.Studies have highlighted that individual developmental care, family education, kangaroo care, and early physiotherapy approaches applied to at-risk infants in the neonatal intensive care unit (NICU) enhance infant development. However, further research is needed to determine the most effective interventions for infants who are more environmentally at risk and biologically vulnerable. Studies investigating the effectiveness of early intervention methods initiated in the NICU on the motor, cognitive, and behavioral outcomes of premature infants have highlighted that postural control interventions or physiotherapy consisting of developmental care programs implemented in the neonatal period improve motor development in the short term, but parent-implemented motor interventions are more effective in improving infants' cognitive and motor outcomes in the long term.The aim of this study is to examine the effects of family-based early physiotherapy approaches applied to at-risk infants in the NICU on motor, cognitive, language development and developmental outcomes at term age and in the long term (adjusted 3, 6, 9, 12 months).
- Being tested
- Early Physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early PhysiotherapyOther
The early physiotherapy program will begin when the infant is stable and continue until discharge. Depending on the infant's gestational age and respiratory needs, chest physiotherapy, developmental physiotherapy, or both will be administered, if necessary. The early family collaborative physiotherapy program will begin from the first day the infant is stable and parental contact is established, and will consist of routine-based care and family education programs that include therapeutic holding, carrying, positioning, and sucking facilitation to stimulate postural responses. The physiotherapy group will receive a routine-based family collaborative early intervention program. This program will be based on a model of goal-oriented active motor learning and sensory strategy development in an enriched environment, and will include family education programs that integrate holding, carrying, and positioning training into daily routines. All parents will participate in the training.
| Study group | Role | What they receive |
|---|---|---|
| early physiotherapy | Experimental | A physiotherapy program tailored to the needs of infants from families who volunteer will be implemented until and including discharge. Parents of all infants discharged from the NICU will receive advice on holding, carrying, and positioning. Receives: Other: Early Physiotherapy |
| Standard of care | No intervention | Infants from families who cannot attend physiotherapy for any reason (those living outside the province, those who cannot attend treatment sessions at the same frequency, working parents) will constitute the control group if they can come to the evaluations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prechtl's General Movements (GMs) Assessment
Prechtl's General Movements (GMs) Assessment: General movements (GMs) are the spontaneous movement repertoire present from early fetal life until the 20th week postpartum. They are "writhing" until the 8th week postpartum and then "fidgety" until approximately the 20th week. Heinz Prechtl demonstrated the validity and reliability of this method by determining that infants without fidgety movements between 3 and 5 months of age are at high risk of developing CP. Video recordings will begin in the NICU 3 days after birth during the preterm period. All infants will be examined for writhing and fidgety movements (FM) using the video recordings. Movements during the preterm and writhing periods will be classified as PR, CS, and Ch GMs or normal. Movements during the fidgety period will be recorded as F+ or F++ when normal, AF when abnormal, or F- when not observed. Motor optimality scores will also be calculated for all infants during the fidgety period.
Measured: writhing movement betweeen birth and 8 weeks of age, Fidgety movements between 12 and 20 weeks of age
Hammersmith Infant Neurological Examination (HINE)
The HINE is a simple, standardized, and scoreable test for the clinical neurological assessment of infants aged 2-24 months. It consists of three sections: (1) a neurological examination that assesses cranial nerve function, posture, movements, tone, reflexes, and reactions; (2) motor milestones; and (3) behavior. Each of the 26 items on the test is first scored individually (0, 1, 2, 3, or half-point). A total score is then calculated, with a maximum score of 78. The total score is classified as optimal or suboptimal. Optimal scores are based on the frequency distribution of neurological findings in the population observed in at least 90% of infants in the age range studied. Higher scores indicate better neurological status.
Measured: It will be applied at the adjusted 2nd, 3rd, 6th, 9th and 12th months.
BAYLEY-III Infant and Child Development Assessment Scale (BAYLEY-III)
The BSID-III is a neurocognitive assessment used to monitor the development of infants aged 0-42 months. It has five domains: cognitive, language, motor, social-emotional, and adaptive functions. This study will assess only the first three domains. Cognitive, language, and fine and gross motor skills will be assessed. A composite score is calculated for each domain (mean 100±15). A composite score below 2 standard deviations (SD) (<70) is considered a severe delay across all domains.
Measured: at 3, 6 and 12th months
Secondary outcomes (3)
Sociodemographic form
Prenatal/perinatal risks (MRI, cUS results, diagnosis, neurological evaluation) of all infants and their parents will be obtained from hospital records after treatment.
Measured: first day of the assessment
Hammersmith Neonatal Neurological Examination
The examination developed by Dubowitz standardized optimality scores by evaluating low-risk term and high-risk preterm infants at term age. The scale consists of a 34-item proforma. This proforma includes tone (10), tone patterns (5), reflexes (6), movements (3), abnormal signs (3), and behavior (7). All items are scored from 1 to 3 (half points are also possible). Higher scores indicate better neurological status.
Measured: 3 days after birth and corrected postterm 40±2 weeks
Body Mass Index (BMI)
Birth weight in kilograms, height in meters will be recorded. Weight and height will be combined to report BMI in kg/m2.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start15 Jan 2027 (estimated)
- Primary completion15 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infants Admitted to Neonatal UnitsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Adiguzel, Kahramanmaras Sutcu Imam University
- Investigators
- hatice adıgüzel tat, Associate Professor, Principal investigator, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201792
- Sponsor's protocol ID
- ACUT PT IN NICU
- Status last verified
- Jul 2025
- First submitted
- 15 Sep 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Physiotherapy Program on the Infants in the Neonatal Intensive Care Unit: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07201792
- Acronym / sponsor ID
- ACUT PT IN NICU
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 15 Jan 2027 (estimated)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 1 Oct 2025 (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.
High-risk of Infants are defined as one with a history of negative environmental and biological factors that could lead to neuromotor developmental problems. This heterogeneous group encompasses premature babies born at less than 37 weeks, term babies with low birth weight (LBW), or babies with developmental delays due to various causes.Studies have highlighted that individual developmental care, family education, kangaroo care, and early physiotherapy approaches applied to at-risk infants in the neonatal intensive care unit (NICU) enhance infant development. However, further research is needed to determine the most effective interventions for infants who are more environmentally at risk and biologically vulnerable. Studies investigating the effectiveness of early intervention methods initiated in the NICU on the motor, cognitive, and behavioral outcomes of premature infants have highlighted that postural control interventions or physiotherapy consisting of developmental care programs implemented in the neonatal period improve motor development in the short term, but parent-implemented motor interventions are more effective in improving infants' cognitive and motor outcomes in the long term.The aim of this study is to examine the effects of family-based early physiotherapy approaches applied to at-risk infants in the NICU on motor, cognitive, language development and developmental outcomes at term age and in the long term (adjusted 3, 6, 9, 12 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early physiotherapy | Experimental | Other: Early PhysiotherapyA physiotherapy program tailored to the needs of infants from families who volunteer will be implemented until and including discharge. Parents of all infants discharged from the NICU will receive advice on holding, carrying, and positioning. |
| Standard of care | No intervention | –Infants from families who cannot attend physiotherapy for any reason (those living outside the province, those who cannot attend treatment sessions at the same frequency, working parents) will constitute the control group if they can come to the evaluations. |
Who may qualify
- Ages
- 28 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Newborns diagnosed with periventricular hemorrhage (PVH), intracranial hemorrhage (ICH), cystic PVL, HIE, kernicterus, perinatal asphyxia, neonatal sepsis, necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP), RDS, or BPD.
- Newborns receiving oxygen or mechanical ventilation (MV) support.
- Infants with a 5-minute Apgar score <3, <37 weeks' gestation, <1500 g preterm, or prematurity due to multiple births.
Key exclusion criteria (1 listed)
- Newborns with congenital malformations (spina bifida, congenital muscular torticollis, arthrogryposis multiplex congenita, etc.), babies diagnosed with metabolic and genetic diseases (down syndrome, spinal muscular atrophy, duchenne muscular dystrophy, etc.)
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 |
|---|---|---|
| Early PhysiotherapyThe early physiotherapy program will begin when the infant is stable and continue until discharge. Depending on the infant's gestational age and respiratory needs, chest physiotherapy, developmental physiotherapy, or both will be administered, if necessary. The early family collaborative physiotherapy program will begin from the first day the infant is stable and parental contact is established, and will consist of routine-based care and family education programs that include therapeutic holding, carrying, positioning, and sucking facilitation to stimulate postural responses. The physiotherapy group will receive a routine-based family collaborative early intervention program. This program will be based on a model of goal-oriented active motor learning and sensory strategy development in an enriched environment, and will include family education programs that integrate holding, carrying, and positioning training into daily routines. All parents will participate in the training. | Other | early physiotherapy |
Primary outcome
Prechtl's General Movements (GMs) Assessment
Time frame: writhing movement betweeen birth and 8 weeks of age, Fidgety movements between 12 and 20 weeks of age
Prechtl's General Movements (GMs) Assessment: General movements (GMs) are the spontaneous movement repertoire present from early fetal life until the 20th week postpartum. They are "writhing" until the 8th week postpartum and then "fidgety" until approximately the 20th week. Heinz Prechtl demonstrated the validity and reliability of this method by determining that infants without fidgety movements between 3 and 5 months of age are at high risk of developing CP. Video recordings will begin in the NICU 3 days after birth during the preterm period. All infants will be examined for writhing and fidgety movements (FM) using the video recordings. Movements during the preterm and writhing periods will be classified as PR, CS, and Ch GMs or normal. Movements during the fidgety period will be recorded as F+ or F++ when normal, AF when abnormal, or F- when not observed. Motor optimality scores will also be calculated for all infants during the fidgety period.
Hammersmith Infant Neurological Examination (HINE)
Time frame: It will be applied at the adjusted 2nd, 3rd, 6th, 9th and 12th months.
The HINE is a simple, standardized, and scoreable test for the clinical neurological assessment of infants aged 2-24 months. It consists of three sections: (1) a neurological examination that assesses cranial nerve function, posture, movements, tone, reflexes, and reactions; (2) motor milestones; and (3) behavior. Each of the 26 items on the test is first scored individually (0, 1, 2, 3, or half-point). A total score is then calculated, with a maximum score of 78. The total score is classified as optimal or suboptimal. Optimal scores are based on the frequency distribution of neurological findings in the population observed in at least 90% of infants in the age range studied. Higher scores indicate better neurological status.
BAYLEY-III Infant and Child Development Assessment Scale (BAYLEY-III)
Time frame: at 3, 6 and 12th months
The BSID-III is a neurocognitive assessment used to monitor the development of infants aged 0-42 months. It has five domains: cognitive, language, motor, social-emotional, and adaptive functions. This study will assess only the first three domains. Cognitive, language, and fine and gross motor skills will be assessed. A composite score is calculated for each domain (mean 100±15). A composite score below 2 standard deviations (SD) (<70) is considered a severe delay across all domains.
3 secondary outcomes
Sociodemographic form
Time frame: first day of the assessment
Hammersmith Neonatal Neurological Examination
Time frame: 3 days after birth and corrected postterm 40±2 weeks
Body Mass Index (BMI)
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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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.
hatice Adiguzel tat, Associate Proffessor contact
hatice adıgüzel tat, Associate Professor principal investigator
Kahramanmaras Sutcu Imam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Physiotherapy in people with Infants Admitted to Neonatal Units and NICU, run by Kahramanmaras Sutcu Imam 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 1 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 14 Jul 2026. 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 hatice adıgüzel tat, Associate Proffessor (0903443002647, fzthatis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prechtl's General Movements (GMs) Assessment (time frame: writhing movement betweeen birth and 8 weeks of age, Fidgety movements between 12 and 20 weeks of age). The study lists 3 primary outcomes in all. 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 14 Jul 2026.