Infant DevelopmentNCT06648213
Individual Structured Therapy in Early Premature Infants at the Neonatal Intensive Care Unit
A study testing Physiotherapy in people with Infant Development and Neonatal Intensive Care Unit, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
In this study, investigators aimed to apply an individual structured therapy protocol within the framework of neurodevelopmental therapy principles in early premature infants hospitalized in the neonatal intensive care unit and to examine its effect on the motor development of infants. Read more about this study
- Who is it for?
- Ages Up to 34 weeksHealthy volunteers can take part
- Conditions the study is for
- Infant Development, Neonatal Intensive Care Unit, INDIVIDUALIZED THERAPY
- What is being tested?
- Physiotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2024to 2 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 34 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Hospitalised in the neonatal intensive care unit,
- Born before 34 weeks of gestation
- medium and low-risk babies
- Newborns who were approved by their families to participate in the study Exclusion criteria
- 1. Diagnosed neurological, neuromuscular or genetic disease 2. Congenital anomalies 3. Newborns whose parents did not consent to participate in the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Individual Structured Therapy Application on Motor Performance in Early Premature Infants Hospitalized in Neonatal Intensive Care Unit
In this study, investigators aimed to apply an individual structured therapy protocol within the framework of neurodevelopmental therapy principles in early premature infants hospitalized in the neonatal intensive care unit and to examine its effect on the motor development of infants.
Read the detailed description
The study is planned to include 20 early premature (<34 weeks) newborns hospitalised in the neonatal intensive care unit. The babies will be divided into two groups as therapy group and control group. Internet-based randomisation system will be used to determine the groups according to their risk levels. The risk levels will be determined according to the guidelines of the Turkish Neonatology Association.
Sterile gowns, masks and bonnets will be used during assessment and therapy to reduce the risk of infection in terms of the safety of the babies, and small lids will be opened so that the physiotherapist's hand can enter to maintain the temperature and oxygen balance in the incubator.
Therapy group: In addition to routine care, they will be arranged according to the needs of the baby in the form of positioning, hand contacts, passive and active movement of the arms and legs for the development of movement, sensory stimuli around the mouth for oral motor organisation. Neurodevelopmental-based application will be applied three days a week, once a day for 10-15 minutes, from the 34th week until 37th week when vital signs are stable.
Control group: They will be monitored by performing routine care and positioning.
- Being tested
- Physiotherapy
- Keywords
- individualized therapy, infant development, neonatal intensive care unit, early preterm
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
Therapy group: In addition to routine care, they will be arranged according to the needs of the baby in the form of positioning, hand contacts, passive and active movement of the arms and legs for the development of movement, sensory stimuli around the mouth for oral motor organisation. Neurodevelopmental-based application will be applied three days a week, once a day for 10-15 minutes, from the 34th week until 36th week when vital signs are stable.
| Study group | Role | What they receive |
|---|---|---|
| Individualized Physiotherapy | Other | Therapy group: In addition to routine care, they will be arranged according to the needs of the baby in the form of positioning, hand contacts, passive and active movement of the arms and legs for the development of movement, sensory stimuli around the mouth for oral motor organisation. Neurodevelopmental-based application will be applied three days a week, once a day for 10-15 minutes, from the 34th week until 36th week when vital signs are stable. Receives: Other: Physiotherapy |
| Control | No intervention | Control group: They will be monitored by performing routine care and positioning. |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Movements
GMs movements are a complex set of movements involving the whole body of the baby, which start to be observed from the 9th week of intrauterine life, change shape after the second month of the postterm period and can be monitored until the 20th week in corrected form.
GMA is a valid and reliable analysis used to determine brain dysfunctions in preterm, term and postterm infants up to the 20th week.
GMA analysis can be performed during sleep or wakefulness in preterm infants.
Measured: For GMA analysis in our study, a 3-5 min video of the babies lying supine outside the incubator will be taken. The videos will be recorded at 34th week and 36th week.
Hammersmith Neonatal Neurological Examination (HNNE)
HNNE is a rapid, practical and easy-to-apply assessment method. It can be used in the assessment of term and preterm babies of different ages within the neonatal period. It is one of the standard methods used to predict the risk of cerebral palsy.
Measured: The HNNE short form will be applied at 34th week and 36th week.
Secondary outcomes (1)
Weigh
Weight gain will be analyzed by recording daily weight.
Measured: Three times a week between 34-36th weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start30 Oct 2024
- Primary completion5 Jun 2025
- Study completion2 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özge ÇANKAYA, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648213
- Sponsor's protocol ID
- SBUNICU
- Status last verified
- Nov 2025
- First submitted
- 16 Oct 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Individual Structured Therapy Application on Motor Performance in Early Premature Infants Hospitalized in Neonatal Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06648213
- Acronym / sponsor ID
- SBUNICU
- Keywords
- individualized therapy, infant development, neonatal intensive care unit, early preterm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 5 Jun 2025 (actual)
- Study completion
- 2 Jul 2025 (actual)
- First posted
- 18 Oct 2024 (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.
In this study, investigators aimed to apply an individual structured therapy protocol within the framework of neurodevelopmental therapy principles in early premature infants hospitalized in the neonatal intensive care unit and to examine its effect on the motor development of infants.
Detailed description
The study is planned to include 20 early premature (<34 weeks) newborns hospitalised in the neonatal intensive care unit. The babies will be divided into two groups as therapy group and control group. Internet-based randomisation system will be used to determine the groups according to their risk levels. The risk levels will be determined according to the guidelines of the Turkish Neonatology Association.
Sterile gowns, masks and bonnets will be used during assessment and therapy to reduce the risk of infection in terms of the safety of the babies, and small lids will be opened so that the physiotherapist's hand can enter to maintain the temperature and oxygen balance in the incubator.
Therapy group: In addition to routine care, they will be arranged according to the needs of the baby in the form of positioning, hand contacts, passive and active movement of the arms and legs for the development of movement, sensory stimuli around the mouth for oral motor organisation. Neurodevelopmental-based application will be applied three days a week, once a day for 10-15 minutes, from the 34th week until 37th week when vital signs are stable.
Control group: They will be monitored by performing routine care and positioning.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized Physiotherapy | Other | Other: PhysiotherapyTherapy group: In addition to routine care, they will be arranged according to the needs of the baby in the form of positioning, hand contacts, passive and active movement of the arms and legs for the development of movement, sensory stimuli around the mouth for oral motor organisation. Neurodevelopmental-based application will be applied three days a week, once a day for 10-15 minutes, from the 34th week until 36th week when vital signs are stable. |
| Control | No intervention | –Control group: They will be monitored by performing routine care and positioning. |
Who may qualify
- Ages
- Up to 34 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Hospitalised in the neonatal intensive care unit,
- Born before 34 weeks of gestation
- medium and low-risk babies
- Newborns who were approved by their families to participate in the study Exclusion criteria
- 1. Diagnosed neurological, neuromuscular or genetic disease 2. Congenital anomalies 3. Newborns whose parents did not consent to participate in the study
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PhysiotherapyTherapy group: In addition to routine care, they will be arranged according to the needs of the baby in the form of positioning, hand contacts, passive and active movement of the arms and legs for the development of movement, sensory stimuli around the mouth for oral motor organisation. Neurodevelopmental-based application will be applied three days a week, once a day for 10-15 minutes, from the 34th week until 36th week when vital signs are stable. | Other | Individualized Physiotherapy |
Primary outcome
General Movements
Time frame: For GMA analysis in our study, a 3-5 min video of the babies lying supine outside the incubator will be taken. The videos will be recorded at 34th week and 36th week.
GMs movements are a complex set of movements involving the whole body of the baby, which start to be observed from the 9th week of intrauterine life, change shape after the second month of the postterm period and can be monitored until the 20th week in corrected form. GMA is a valid and reliable analysis used to determine brain dysfunctions in preterm, term and postterm infants up to the 20th week. GMA analysis can be performed during sleep or wakefulness in preterm infants.
Hammersmith Neonatal Neurological Examination (HNNE)
Time frame: The HNNE short form will be applied at 34th week and 36th week.
HNNE is a rapid, practical and easy-to-apply assessment method. It can be used in the assessment of term and preterm babies of different ages within the neonatal period. It is one of the standard methods used to predict the risk of cerebral palsy.
1 secondary outcome
Weigh
Time frame: Three times a week between 34-36th weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Infant Development and Neonatal Intensive Care Unit, run by Hacettepe 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 0 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: finished, as of the sponsor's last update on 24 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Movements (time frame: For GMA analysis in our study, a 3-5 min video of the babies lying supine outside the incubator will be taken. The videos will be recorded at 34th week and 36th week.). The study lists 2 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 24 Nov 2025.