Neonatal Neurobehavioral And Motor Behavior In Ultra Early Physical Therapy Intervention
NCT ID: NCT05565287
Last Updated: 2025-06-17
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
EARLY_PHASE1
80 participants
INTERVENTIONAL
2021-09-24
2025-12-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
2. group: Basic hospital guidelines
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Brazelton and Prechtl Assessment Group
Parental advise and intervention based on the combination of neonatal neurobehaviourism (Brazelton) and motor behaviour (Prechtl)
ultra early physiotherapy intervention
* 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).
No intervention group
Basic hospital guidelines
No interventions assigned to this group
Interventions
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ultra early physiotherapy intervention
* 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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Premature newborns hospitalised in the NICU for at least eight days
* (for parents) be able to speak and read Greek or English
Exclusion Criteria
* Newborns with severe accompanying pathological problems and congenital infections.
* (for parents) with known history of drug or alcohol abuse or serious psychiatric disorders
3 Months
ALL
Yes
Sponsors
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University of Thessaly
OTHER
Responsible Party
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Moscholouri Chrysoula
Principal Investigator
Principal Investigators
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Panagiotis N Triggas, Assistant Profesor
Role: STUDY_DIRECTOR
University of Thessaly
Locations
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PAGNI University Hospital
Heraklion, Crete, Greece
Attikon Hospital
Athens, Haidari, Greece
University of Thessaly
Lamia, , Greece
Countries
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References
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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.
Aita 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.
Volpe JJ. Brain injury in the premature infant--current concepts of pathogenesis and prevention. Biol Neonate. 1992;62(4):231-42. doi: 10.1159/000243876.
Prechtl 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.
Bekedam 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.
Geerdink 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.
Craciunoiu 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.
Noble 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.
Aita 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.
Malak 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.
Aita 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.
Raghupathy 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.
Other Identifiers
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MC10107802620
Identifier Type: -
Identifier Source: org_study_id
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