Neonatal DiseaseEarly Phase 1NCT05565287
Neonatal Neurobehavioral And Motor Behavior In Ultra Early Physical Therapy Intervention
A Early Phase 1 study testing ultra early physiotherapy intervention in people with Neonatal Disease and Parenting, run by University of Thessaly at 3 sites in Greece.
Trial summary
Investigation of the combination of neonatal neurobehaviourism and motor behavior in the assessment and ultra-early physical therapy intervention of premature neonates and parental support. Read more about this study
- Who is it for?
- Ages Up to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Neonatal Disease, Parenting, Premature Birth
- What is being tested?
- ultra early physiotherapy intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesGreece
- Study dates
- 24 Sep 2021to 30 Dec 2025
- Phase
- Early Phase 1
- 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 Up to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestational age under 37 weeks
- Premature newborns hospitalised in the NICU for at least eight days
- (for parents) be able to speak and read Greek or English
Who cannot join
- Newborns with congenital and chromosomal abnormalities.
- Newborns with severe accompanying pathological problems and congenital infections.
- (for parents) with known history of drug or alcohol abuse or serious psychiatric disorders
Trial locations and contacts
3 sites in 1 country.
Greece3 sites
Attikon Hospital
Athens, Haidari, 124 62
PAGNI University Hospital
Heraklion, Crete, 711 10
University of Thessaly
Lamia, 35100
About this study
Official title: Combining Neonatal Neurobehavioral (Brazelton) And Motor Behavior (Prechtl) In The Assessment And Ultra Early Physical Therapy Intervention Of Premature Infants
Investigation of the combination of neonatal neurobehaviourism and motor behavior in the assessment and ultra-early physical therapy intervention of premature neonates and parental support.
Read the detailed description
Developments in neonatology and perinatal medicine in recent years have resulted in a remarkable development of the survival of premature infants. At the same time, several evaluation and intervention protocols have been developed, aiming at early diagnosis and intervention, but also and studies that are concluding and highlight the need for future well planed and in-depth research, mainly in areas related to early intervention. T. Brazeltons' (1973) Neonatal Behavioural Assessment Scale (NBAS) has been used in many studies of assessment and intervention in newborn-infant and their families and respectively H.R. Prechtls' (1979) Qualitative Assessment of General Movements (GMs) in assessment studies, as a valid and reliable non-invasive procedure. However, the combination of their basic principles and guidelines has not been developed and tested in the context of ultra-early physiotherapy intervention in premature infants.
The evaluation and strengthening of ultra-early physiotherapy intervention by combining basic principles of neonatal neuro-behavior (based on Brazelton T.) and motor behavior (based on Prechtl H.F.R.), in the context of individualized and developmental supportive care of premature neonates and infants and enhancing parental self-confidence.
The research is based upon on three different researches: a) the cross-cultural adaptation of Karitane Parental Confidence Scale (KPCS) questionnaire. The sample will be parents of infants up to one year, b) the effect of ultra-early intervention on parental confidence of preterm infant parents. An experimental randomized controlled trial which will be conducted in the Neonatal Intensive Care Unit (NICU) until maternity hospital discharge. The sample will be premature infants and their parents and c) the effect of ultra-early intervention and parental confidence, on the development of premature infants up to the age of three months. An experimental randomized controlled trial which will be conducted in the Neonatal Intensive Care Unit (NICU) and upon their discharge from the maternity hospital up to the age of 3 months. The study sample will be premature infants and their parents.
- Conditions
- Neonatal Disease, Parenting, Premature Birth
- Being tested
- ultra early physiotherapy intervention
- Keywords
- prematurity, subsystem organization, motor system, state system, general movements, spontaneous mobility, parental confidence, neonatal neurobehavior
- Medical subject headings
- Infant, Newborn, Diseases, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultra early physiotherapy interventionCombination product
Also called Neurobehavioral Concept (Brazelton), Motor Behavioural Concept (Prechtl)
- NBAS / NBO and GMs based guidelines in explaining neonatal "signs" into the NICU (lasting 15-30 minutes)
- NBAS / NBO and GMs based guidelines in explaining neonatal "signs" to parents, 1st neonatal assessment and intervention upon hospital discharge (lasting one hour)
- NBAS / NBO and GMs based guidelines in explaining neonatal "signs" to parents, 1st neonatal assessment and intervention every 15 to 20 days until the 3rd month of life (corrected age).
| Study group | Role | What they receive |
|---|---|---|
| Brazelton and Prechtl Assessment Group | Experimental | Parental advise and intervention based on the combination of neonatal neurobehaviourism (Brazelton) and motor behaviour (Prechtl) Receives: Combination Product: ultra early physiotherapy intervention |
| No intervention group | No intervention | Basic hospital guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
The neonatal behavioural assessment scale (NBAS)
Assesses neurobehavioral repertoire of the newborn
Measured: newborn - 2 month old (corrected age)
The New-born Behavioral Observations (NBO)
latest and inspired by the clinical uses of NBAS. Αn interactive relationship-building tool to strengthen the relationship between infants and parents beginning in the newborn period
Measured: Βirth through the 3rd month of life
The Qualitative Assessment of General Movements (GMsA)
non-invasive and non-disruptive assessment through observations of the quality of generalised movements to determine the integrity of the CNS of infants
Measured: birth to 20 weeks (corrected age)
• Karitane Parenting Confidence Scale (KPCS) (Crncec, R., et all., 2008, 2010)
Assesses perceived parental confidence in newborn/infant care
Measured: Birth to 12 months
• Parental Stressor Scale: Neonatal Intensive Care Unit (Pss: Nicu) (Miles, M. S., Funk, S. G., & Carlson, J., 1993)
Parental Self Reported Questionnaire concerning their experiences in NICU
Measured: From Enrollment to the end of interventional 3 months
Secondary outcomes (1)
Parental Stress Scale (PSS-18) (Berry, J., O., & Jones., W., H., 1995)
Parental Self Reported Questionnaire concerning their parental experience
Measured: From enrollment to the end of program at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start24 Sep 2021
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Neonatal DiseaseStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. group: Intervention Parental advise based on the combination of neonatal neurobehaviourism and motor behaviour 2. group: Basic hospital guidelines
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moscholouri Chrysoula, University of Thessaly
- Investigators
- Panagiotis N Triggas, Assistant Profesor, Study director, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565287
- Sponsor's protocol ID
- MC10107802620
- Status last verified
- Mar 2025
- First submitted
- 29 Sep 2022
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Als H. The newborn communicates. J Commun. 1977 Spring;27(2):66-73. doi: 10.1111/j.1460-2466.1977.tb01828.x. No abstract available.
PubMed 853137Aita M, Snider L. The art of developmental care in the NICU: a concept analysis. J Adv Nurs. 2003 Feb;41(3):223-32. doi: 10.1046/j.1365-2648.2003.02526.x.
PubMed 12581110Volpe JJ. Brain injury in the premature infant--current concepts of pathogenesis and prevention. Biol Neonate. 1992;62(4):231-42. doi: 10.1159/000243876.
PubMed 1420621Prechtl HF. Qualitative changes of spontaneous movements in fetus and preterm infant are a marker of neurological dysfunction. Early Hum Dev. 1990 Sep;23(3):151-8. doi: 10.1016/0378-3782(90)90011-7. No abstract available.
PubMed 2253578Bekedam DJ, Visser GH, de Vries JJ, Prechtl HF. Motor behaviour in the growth retarded fetus. Early Hum Dev. 1985 Nov;12(2):155-65. doi: 10.1016/0378-3782(85)90178-1.
PubMed 3905347Geerdink JJ, Hopkins B. Qualitative changes in general movements and their prognostic value in preterm infants. Eur J Pediatr. 1993 Apr;152(4):362-7. doi: 10.1007/BF01956755.
PubMed 8482291Craciunoiu O, Holsti L. A Systematic Review of the Predictive Validity of Neurobehavioral Assessments During the Preterm Period. Phys Occup Ther Pediatr. 2017 Aug;37(3):292-307. doi: 10.1080/01942638.2016.1185501. Epub 2016 Jun 17.
PubMed 27314272Noble Y, Boyd R. Neonatal assessments for the preterm infant up to 4 months corrected age: a systematic review. Dev Med Child Neurol. 2012 Feb;54(2):129-39. doi: 10.1111/j.1469-8749.2010.03903.x. Epub 2011 Dec 5.
PubMed 22142216Aita M, Stremler R, Feeley N, Lavallee A, De Clifford-Faugere G. Effectiveness of interventions during NICU hospitalization on the neurodevelopment of preterm infants: a systematic review protocol. Syst Rev. 2017 Nov 3;6(1):225. doi: 10.1186/s13643-017-0613-5.
PubMed 29100533Malak R, Fechner B, Sikorska D, Rosolek M, Mojs E, Samborski W, Baum E. Application of the Neonatal Behavioral Assessment Scale to Evaluate the Neurobehavior of Preterm Neonates. Brain Sci. 2021 Sep 28;11(10):1285. doi: 10.3390/brainsci11101285.
PubMed 34679350Aita M, De Clifford Faugere G, Lavallee A, Feeley N, Stremler R, Rioux E, Proulx MH. Effectiveness of interventions on early neurodevelopment of preterm infants: a systematic review and meta-analysis. BMC Pediatr. 2021 Apr 29;21(1):210. doi: 10.1186/s12887-021-02559-6.
PubMed 33926417Raghupathy MK, Rao BK, Nayak SR, Spittle AJ, Parsekar SS. Effect of family-centered care interventions on motor and neurobehavior development of very preterm infants: a protocol for systematic review. Syst Rev. 2021 Feb 18;10(1):59. doi: 10.1186/s13643-021-01612-w.
PubMed 33602324
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Neonatal Neurobehavioral (Brazelton) And Motor Behavior (Prechtl) In The Assessment And Ultra Early Physical Therapy Intervention Of Premature Infants
- ClinicalTrials.gov ID
- NCT05565287
- Acronym / sponsor ID
- MC10107802620
- Conditions
- Neonatal Disease, Parenting, Premature Birth
- Keywords
- prematurity, subsystem organization, motor system, state system, general movements, spontaneous mobility, parental confidence, neonatal neurobehavior
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 4 Oct 2022 (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.
Investigation of the combination of neonatal neurobehaviourism and motor behavior in the assessment and ultra-early physical therapy intervention of premature neonates and parental support.
Detailed description
Developments in neonatology and perinatal medicine in recent years have resulted in a remarkable development of the survival of premature infants. At the same time, several evaluation and intervention protocols have been developed, aiming at early diagnosis and intervention, but also and studies that are concluding and highlight the need for future well planed and in-depth research, mainly in areas related to early intervention. T. Brazeltons' (1973) Neonatal Behavioural Assessment Scale (NBAS) has been used in many studies of assessment and intervention in newborn-infant and their families and respectively H.R. Prechtls' (1979) Qualitative Assessment of General Movements (GMs) in assessment studies, as a valid and reliable non-invasive procedure. However, the combination of their basic principles and guidelines has not been developed and tested in the context of ultra-early physiotherapy intervention in premature infants.
The evaluation and strengthening of ultra-early physiotherapy intervention by combining basic principles of neonatal neuro-behavior (based on Brazelton T.) and motor behavior (based on Prechtl H.F.R.), in the context of individualized and developmental supportive care of premature neonates and infants and enhancing parental self-confidence.
The research is based upon on three different researches: a) the cross-cultural adaptation of Karitane Parental Confidence Scale (KPCS) questionnaire. The sample will be parents of infants up to one year, b) the effect of ultra-early intervention on parental confidence of preterm infant parents. An experimental randomized controlled trial which will be conducted in the Neonatal Intensive Care Unit (NICU) until maternity hospital discharge. The sample will be premature infants and their parents and c) the effect of ultra-early intervention and parental confidence, on the development of premature infants up to the age of three months. An experimental randomized controlled trial which will be conducted in the Neonatal Intensive Care Unit (NICU) and upon their discharge from the maternity hospital up to the age of 3 months. The study sample will be premature infants and their parents.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1. group: Intervention Parental advise based on the combination of neonatal neurobehaviourism and motor behaviour 2. group: Basic hospital guidelines
| Arm | Type | Receives |
|---|---|---|
| Brazelton and Prechtl Assessment Group | Experimental | Combination Product: ultra early physiotherapy interventionParental advise and intervention based on the combination of neonatal neurobehaviourism (Brazelton) and motor behaviour (Prechtl) |
| No intervention group | No intervention | –Basic hospital guidelines |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Gestational age under 37 weeks
- Premature newborns hospitalised in the NICU for at least eight days
- (for parents) be able to speak and read Greek or English
Key exclusion criteria (3 listed)
- Newborns with congenital and chromosomal abnormalities.
- Newborns with severe accompanying pathological problems and congenital infections.
- (for parents) with known history of drug or alcohol abuse or serious psychiatric disorders
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 |
|---|---|---|
| ultra early physiotherapy interventionAlso: Neurobehavioral Concept (Brazelton), Motor Behavioural Concept (Prechtl)* NBAS / NBO and GMs based guidelines in explaining neonatal "signs" into the NICU (lasting 15-30 minutes) * NBAS / NBO and GMs based guidelines in explaining neonatal "signs" to parents, 1st neonatal assessment and intervention upon hospital discharge (lasting one hour) * NBAS / NBO and GMs based guidelines in explaining neonatal "signs" to parents, 1st neonatal assessment and intervention every 15 to 20 days until the 3rd month of life (corrected age). | Combination product | Brazelton and Prechtl Assessment Group |
Primary outcome
The neonatal behavioural assessment scale (NBAS)
Time frame: newborn - 2 month old (corrected age)
Assesses neurobehavioral repertoire of the newborn
The New-born Behavioral Observations (NBO)
Time frame: Βirth through the 3rd month of life
latest and inspired by the clinical uses of NBAS. Αn interactive relationship-building tool to strengthen the relationship between infants and parents beginning in the newborn period
The Qualitative Assessment of General Movements (GMsA)
Time frame: birth to 20 weeks (corrected age)
non-invasive and non-disruptive assessment through observations of the quality of generalised movements to determine the integrity of the CNS of infants
• Karitane Parenting Confidence Scale (KPCS) (Crncec, R., et all., 2008, 2010)
Time frame: Birth to 12 months
Assesses perceived parental confidence in newborn/infant care
• Parental Stressor Scale: Neonatal Intensive Care Unit (Pss: Nicu) (Miles, M. S., Funk, S. G., & Carlson, J., 1993)
Time frame: From Enrollment to the end of interventional 3 months
Parental Self Reported Questionnaire concerning their experiences in NICU
1 secondary outcome
Parental Stress Scale (PSS-18) (Berry, J., O., & Jones., W., H., 1995)
Time frame: From enrollment to the end of program at 3 months
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 17 Jun 2025.
- Background: PubMed 853137Als H. The newborn communicates. J Commun. 1977 Spring;27(2):66-73. doi: 10.1111/j.1460-2466.1977.tb01828.x. No abstract available.
- Background: PubMed 12581110Aita M, Snider L. The art of developmental care in the NICU: a concept analysis. J Adv Nurs. 2003 Feb;41(3):223-32. doi: 10.1046/j.1365-2648.2003.02526.x.
- Background: PubMed 1420621Volpe JJ. Brain injury in the premature infant--current concepts of pathogenesis and prevention. Biol Neonate. 1992;62(4):231-42. doi: 10.1159/000243876.
- Background: PubMed 2253578Prechtl HF. Qualitative changes of spontaneous movements in fetus and preterm infant are a marker of neurological dysfunction. Early Hum Dev. 1990 Sep;23(3):151-8. doi: 10.1016/0378-3782(90)90011-7. No abstract available.
- Background: PubMed 3905347Bekedam DJ, Visser GH, de Vries JJ, Prechtl HF. Motor behaviour in the growth retarded fetus. Early Hum Dev. 1985 Nov;12(2):155-65. doi: 10.1016/0378-3782(85)90178-1.
- Background: PubMed 8482291Geerdink JJ, Hopkins B. Qualitative changes in general movements and their prognostic value in preterm infants. Eur J Pediatr. 1993 Apr;152(4):362-7. doi: 10.1007/BF01956755.
- Background: PubMed 27314272Craciunoiu O, Holsti L. A Systematic Review of the Predictive Validity of Neurobehavioral Assessments During the Preterm Period. Phys Occup Ther Pediatr. 2017 Aug;37(3):292-307. doi: 10.1080/01942638.2016.1185501. Epub 2016 Jun 17.
- Background: PubMed 22142216Noble Y, Boyd R. Neonatal assessments for the preterm infant up to 4 months corrected age: a systematic review. Dev Med Child Neurol. 2012 Feb;54(2):129-39. doi: 10.1111/j.1469-8749.2010.03903.x. Epub 2011 Dec 5.
- Background: PubMed 29100533Aita M, Stremler R, Feeley N, Lavallee A, De Clifford-Faugere G. Effectiveness of interventions during NICU hospitalization on the neurodevelopment of preterm infants: a systematic review protocol. Syst Rev. 2017 Nov 3;6(1):225. doi: 10.1186/s13643-017-0613-5.
- Background: PubMed 34679350Malak R, Fechner B, Sikorska D, Rosolek M, Mojs E, Samborski W, Baum E. Application of the Neonatal Behavioral Assessment Scale to Evaluate the Neurobehavior of Preterm Neonates. Brain Sci. 2021 Sep 28;11(10):1285. doi: 10.3390/brainsci11101285.
- Background: PubMed 33926417Aita M, De Clifford Faugere G, Lavallee A, Feeley N, Stremler R, Rioux E, Proulx MH. Effectiveness of interventions on early neurodevelopment of preterm infants: a systematic review and meta-analysis. BMC Pediatr. 2021 Apr 29;21(1):210. doi: 10.1186/s12887-021-02559-6.
- Background: PubMed 33602324Raghupathy MK, Rao BK, Nayak SR, Spittle AJ, Parsekar SS. Effect of family-centered care interventions on motor and neurobehavior development of very preterm infants: a protocol for systematic review. Syst Rev. 2021 Feb 18;10(1):59. doi: 10.1186/s13643-021-01612-w.
- 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. This study is not recruiting at the moment.
Panagiotis N Triggas, Assistant Profesor study director
University of Thessaly
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ultra early physiotherapy intervention in people with Neonatal Disease and Parenting, run by University of Thessaly at 3 sites in Greece.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Greece. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
The neonatal behavioural assessment scale (NBAS) (time frame: newborn - 2 month old (corrected age)). The study lists 5 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 NCT05565287, which also lists 12 linked publications.
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 17 Jun 2025.