Clinical trial NCT05565287: Neonatal Neurobehavioral And Motor Behavior In Ultra Early Physical Therapy Intervention
Official title: Combining Neonatal Neurobehavioral (Brazelton) And Motor Behavior (Prechtl) In The Assessment And Ultra Early Physical Therapy Intervention Of Premature Infants
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Neonatal Disease
Parenting
Premature Birth
Keywords: prematurity
subsystem organization
motor system
state system
general movements
spontaneous mobility
parental confidence
neonatal neurobehavior
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 80
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. group: Intervention Parental advise based on the combination of neonatal neurobehaviourism and motor behaviour
2. group: Basic hospital guidelines
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The neonatal behavioural assessment scale (NBAS)
timeFrame: newborn - 2 month old (corrected age)
measure: The New-born Behavioral Observations (NBO)
timeFrame: Βirth through the 3rd month of life
measure: The Qualitative Assessment of General Movements (GMsA)
timeFrame: birth to 20 weeks (corrected age)
measure: • Karitane Parenting Confidence Scale (KPCS) (Crncec, R., et all., 2008, 2010)
timeFrame: Birth to 12 months
measure: • Parental Stressor Scale: Neonatal Intensive Care Unit (Pss: Nicu) (Miles, M. S., Funk, S. G., & Carlson, J., 1993)
timeFrame: From Enrollment to the end of interventional 3 months
Secondary outcomes:
measure: Parental Stress Scale (PSS-18) (Berry, J., O., & Jones., W., H., 1995)
timeFrame: From enrollment to the end of program at 3 months
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: PAGNI University Hospital
state: Crete
city: Athens
country: Greece
facility: Attikon Hospital
state: Haidari
city: Lamia
country: Greece
facility: University of Thessaly
Study officials:
affiliation: University of Thessaly
name: Panagiotis N Triggas, Assistant Profesor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.