Premature; Infant, Light-for-datesNCT05845684
The Effect of the Physiotherapy Program Applied in the Neonatal Intensive Care Unit
A study testing Physiotherapy application in people with Premature; Infant, Light-for-dates and Neonatal Disease, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to examine the effects of the physiotherapy program applied in the NICU on motor performance, behavior, transition time to full enteral feeding, and feeding performance in preterm infants. Read more about this study
- Who is it for?
- Ages 10 days to 20 weeks
- Conditions the study is for
- Premature; Infant, Light-for-dates, Neonatal Disease, Neurodevelopmental Disorders
- What is being tested?
- Physiotherapy application
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Dec 2021to 25 Apr 2023
- 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 10 days to 20 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Born 30 weeks or younger of gestational age, Body weight below 1500 g, The baby's vital signs are stable.
Who cannot join
- Infants undergo surgery, Taking antibiotics or phototherapy, Having a genetic syndrome • Having other medical conditions that may affect physiotherapy practices, such as multiple congenital anomalies, tracheoesophageal fistula, diaphragmatic hernia, congenital heart malformation, and/or necrotizing enterocolitis, The baby is intubated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Yenidoğan yoğun bakımda Uygulanan Fizyoterapi programının prematüre Bebeklerin Motor ve Beslenme performansına Etkisi
The aim of our study is to examine the effects of the physiotherapy program applied in the NICU on motor performance, behavior, transition time to full enteral feeding, and feeding performance in preterm infants.
Read the detailed description
Preterm babies have to stay in neonatal intensive care units (NICU) because they cannot complete intrauterine development and have difficulty maintaining their vital functions.
In very low birth weight babies, feeding may not be started at the desired time due to medical problems. Total parenteral nutrition should be started in order to prevent growth retardation in the baby who cannot receive adequate enteral nutrition in the first days. The infant who tolerates enteral feeding should also be transitioned to full enteral feeding as soon as possible. Early enteral nutrition and intensive early parenteral nutrition reduce growth retardation and improve the infant's mental developmental scores. The frequent occurrence of feeding intolerance in preterm infants with very low birth weight, especially extremely low birth weight, and the risk of NEC, which is a serious cause of mortality and morbidity in these infants, prevent reaching the desired nutritional goals. Therefore, the optimum initiation time and rate of increase of enteral feeding are still uncertain for these infants. The main purpose of preterm nutrition should be to minimize the problems that may occur in the short and long term. The aim of our study is to examine the effects of the physiotherapy program applied in the NICU on motor performance, behavior, transition time to full enteral feeding and feeding performance in preterm infants.
- Conditions
- Premature; Infant, Light-for-dates, Neonatal Disease, Neurodevelopmental Disorders, Motor Delay
- Being tested
- Physiotherapy application, Control Group
- Medical subject headings
- Premature Birth, Infant, Newborn, Diseases, Neurodevelopmental Disorders, Psychomotor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy applicationOther
massage, oral and intraoral tactile stimuli and non-nutritive sucking will be performed to stimulate sucking, and massage applications and neurodevelopmental therapy for motor development.
Control GroupOther
standard daily applications will be performed on patients
| Study group | Role | What they receive |
|---|---|---|
| trial group | Experimental | The physiotherapy group will receive a 10-minute massage in 30-minute sessions, 3 days a week for 1 month, oral and intraoral tactile stimulations, and non-nutritive sucking exercises to stimulate sucking. Positioning will be done for 15 minutes for mobilization purposes. Receives: Other: Physiotherapy application |
| control group | Other | In the control group, daily standard care practices will be performed. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dubowitz Neurological Assessment
Neurological assessment of the newborn infant.
Measured: 10 minutes
Preterm Oral Feeding Readiness Assessment Scale
preterm infant oral feeding readiness instrument consisting of items in relation to corrected gestational age, behavioral state, global posture and tone, gag reflex, tongue movement and cupping, jaw movements and maintenance of an alert state
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start31 Dec 2021
- Primary completion1 Apr 2023
- Study completion25 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature; Infant, Light-for-datesStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilay Comuk Balci, Ondokuz Mayıs University
- Investigators
- Nilay Comuk Balci, Principal investigator, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845684
- Sponsor's protocol ID
- 2021/608
- Status last verified
- May 2023
- First submitted
- 26 Apr 2023
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Comuk Balci N, Takci S, Seren HC. Improving feeding skills and transition to breastfeeding in early preterm infants: a randomized controlled trial of oromotor intervention. Front Pediatr. 2023 Sep 18;11:1252254. doi: 10.3389/fped.2023.1252254. eCollection 2023.
PubMed 37790695
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yenidoğan yoğun bakımda Uygulanan Fizyoterapi programının prematüre Bebeklerin Motor ve Beslenme performansına Etkisi
- ClinicalTrials.gov ID
- NCT05845684
- Acronym / sponsor ID
- 2021/608
- Conditions
- Premature; Infant, Light-for-dates, Neonatal Disease, Neurodevelopmental Disorders, Motor Delay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 31 Dec 2021 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 25 Apr 2023 (actual)
- First posted
- 6 May 2023 (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.
The aim of our study is to examine the effects of the physiotherapy program applied in the NICU on motor performance, behavior, transition time to full enteral feeding, and feeding performance in preterm infants.
Detailed description
Preterm babies have to stay in neonatal intensive care units (NICU) because they cannot complete intrauterine development and have difficulty maintaining their vital functions.
In very low birth weight babies, feeding may not be started at the desired time due to medical problems. Total parenteral nutrition should be started in order to prevent growth retardation in the baby who cannot receive adequate enteral nutrition in the first days. The infant who tolerates enteral feeding should also be transitioned to full enteral feeding as soon as possible. Early enteral nutrition and intensive early parenteral nutrition reduce growth retardation and improve the infant's mental developmental scores. The frequent occurrence of feeding intolerance in preterm infants with very low birth weight, especially extremely low birth weight, and the risk of NEC, which is a serious cause of mortality and morbidity in these infants, prevent reaching the desired nutritional goals. Therefore, the optimum initiation time and rate of increase of enteral feeding are still uncertain for these infants. The main purpose of preterm nutrition should be to minimize the problems that may occur in the short and long term. The aim of our study is to examine the effects of the physiotherapy program applied in the NICU on motor performance, behavior, transition time to full enteral feeding and feeding performance in preterm infants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trial group | Experimental | Other: Physiotherapy applicationThe physiotherapy group will receive a 10-minute massage in 30-minute sessions, 3 days a week for 1 month, oral and intraoral tactile stimulations, and non-nutritive sucking exercises to stimulate sucking. Positioning will be done for 15 minutes for mobilization purposes. |
| control group | Other | Other: Control GroupIn the control group, daily standard care practices will be performed. |
Who may qualify
- Ages
- 10 days to 20 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Born 30 weeks or younger of gestational age, Body weight below 1500 g, The baby's vital signs are stable.
Key exclusion criteria (1 listed)
- Infants undergo surgery, Taking antibiotics or phototherapy, Having a genetic syndrome • Having other medical conditions that may affect physiotherapy practices, such as multiple congenital anomalies, tracheoesophageal fistula, diaphragmatic hernia, congenital heart malformation, and/or necrotizing enterocolitis, The baby is intubated.
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 |
|---|---|---|
| Physiotherapy applicationmassage, oral and intraoral tactile stimuli and non-nutritive sucking will be performed to stimulate sucking, and massage applications and neurodevelopmental therapy for motor development. | Other | trial group |
| Control Groupstandard daily applications will be performed on patients | Other | control group |
Primary outcome
Dubowitz Neurological Assessment
Time frame: 10 minutes
Neurological assessment of the newborn infant.
Preterm Oral Feeding Readiness Assessment Scale
Time frame: 10 minutes
preterm infant oral feeding readiness instrument consisting of items in relation to corrected gestational age, behavioral state, global posture and tone, gag reflex, tongue movement and cupping, jaw movements and maintenance of an alert state
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 11 May 2023.
- Derived from this study: PubMed 37790695Comuk Balci N, Takci S, Seren HC. Improving feeding skills and transition to breastfeeding in early preterm infants: a randomized controlled trial of oromotor intervention. Front Pediatr. 2023 Sep 18;11:1252254. doi: 10.3389/fped.2023.1252254. eCollection 2023.
- Individual participant dataSharing planned: No
Related trials for Premature; Infant, Light-for-dates
Active, not recruiting
Early DHA/ARA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial
Infant Malnutrition, Light-For-Dates With Signs of Fetal Malnutrition
Active, not recruiting
Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants
Prematurity, Light-For-Dates
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.
Nilay Comuk Balci principal investigator
Ondokuz Mayıs 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 Physiotherapy application in people with Premature; Infant, Light-for-dates and Neonatal Disease, run by Ondokuz Mayıs 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 1 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: finished, as of the sponsor's last update on 11 May 2023. 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?
Dubowitz Neurological Assessment (time frame: 10 minutes). 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?
On the ClinicalTrials.gov record for NCT05845684, which also lists 1 linked publication.
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 11 May 2023.