Neonatal Neurobehavioral And Motor Behavior In Ultra Early Physical Therapy Intervention

NCT05565287 | Active Not Recruiting Early Phase 1 DMC

• 1 other identifier: MC10107802620
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Neonatal Disease; Parenting; Premature Birth

Keywords

prematurity; subsystem organization; motor system; state system; general movements; spontaneous mobility; parental confidence; neonatal neurobehavior

Outcome Measures

Primary Outcomes (5)

• The neonatal behavioural assessment scale (NBAS)

  Assesses neurobehavioral repertoire of the newborn

  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

  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

  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

  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

  From Enrollment to the end of interventional 3 months

Secondary Outcomes (1)

• Parental Stress Scale (PSS-18) (Berry, J., O., & Jones., W., H., 1995)

  From enrollment to the end of program at 3 months

Study Arms (2)

Brazelton and Prechtl Assessment Group

EXPERIMENTAL

Parental advise and intervention based on the combination of neonatal neurobehaviourism (Brazelton) and motor behaviour (Prechtl)

Combination Product: ultra early physiotherapy intervention

No intervention group

NO INTERVENTION

Basic hospital guidelines

Interventions

ultra early physiotherapy intervention COMBINATION_PRODUCT

* 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).

Also known as: Neurobehavioral Concept (Brazelton), Motor Behavioural Concept (Prechtl)

Brazelton and Prechtl Assessment Group

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (3)

PAGNI University Hospital

Heraklion, Crete, 711 10, Greece

Location

Attikon Hospital

Athens, Haidari, 124 62, Greece

Location

University of Thessaly

Lamia, 35100, Greece

Location

Related Publications (12)

• 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.

  PMID: 853137 BACKGROUND

• 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.

  PMID: 12581110 BACKGROUND

• 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.

  PMID: 1420621 BACKGROUND

• 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.

  PMID: 2253578 BACKGROUND

• 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.

  PMID: 3905347 BACKGROUND

• 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.

  PMID: 8482291 BACKGROUND

• 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.

  PMID: 27314272 BACKGROUND

• 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.

  PMID: 22142216 BACKGROUND

• 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.

  PMID: 29100533 BACKGROUND

• 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.

  PMID: 34679350 BACKGROUND

• 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.

  PMID: 33926417 BACKGROUND

• 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.

  PMID: 33602324 BACKGROUND

MeSH Terms

Conditions

Infant, Newborn, Diseases; Premature Birth

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Panagiotis N Triggas, Assistant Profesor

  University of Thessaly

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: prematurity (NICU)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 1. group: Intervention Parental advise based on the combination of neonatal neurobehaviourism and motor behaviour 2. group: Basic hospital guidelines

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 4, 2022
• Study Start: September 24, 2021
• Primary Completion: October 30, 2025
• Study Completion: December 30, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (3)