Neonatal Neurobehavioral And Motor Behavior In Ultra Early Physical Therapy Intervention

Premature Birth Clinical Trial

Official title:

Combining Neonatal Neurobehavioral (Brazelton) And Motor Behavior (Prechtl) In The Assessment And Ultra Early Physical Therapy Intervention Of Premature Infants

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05565287
• Other study ID #: MC10107802620
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 24, 2021
• Est. completion date: March 30, 2025

Study information

• Verified date: November 2022
• Source: University of Thessaly
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: March 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 3 Months

Eligibility

Inclusion Criteria:

• Gestational age under 34 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

Related Conditions & MeSH terms

• Infant, Newborn, Diseases
• Neonatal Disease
• Parenting
• Premature Birth

Intervention

Combination Product:
• 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).

Locations

Country	Name	City	State
Greece	Private abd Public Sector	Lamia

Sponsors (1)

Lead Sponsor	Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

References & Publications (12)

Aita M, De Clifford Faugère G, Lavallée A, Feeley N, Stremler R, Rioux É, 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. — View 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. — View Citation

Aita M, Stremler R, Feeley N, Lavallée A, De Clifford-Faugère 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. — View Citation

Als H. The newborn communicates. J Commun. 1977 Spring;27(2):66-73. — View 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. — View 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. Review. — View 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. — View 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). pii: 1285. doi: 10.3390/brainsci11101285. — View 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. Review. — View 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. — View 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. — View Citation

Volpe JJ. Brain injury in the premature infant--current concepts of pathogenesis and prevention. Biol Neonate. 1992;62(4):231-42. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The neonatal behavioural assessment scale (NBAS)	Assesses neurobehavioral repertoire of the newborn	newborn - 2 month old (corrected age)
Primary	The New-born Behavioral Observations (NBO)	latest and inspired by the clinical uses of NBAS. ?n interactive relationship-building tool to strengthen the relationship between infants and parents beginning in the newborn period	?irth through the 3rd month of life
Primary	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)
Primary	Karitane Parenting Confidence scale (KPCS)	Assesses perceived parental confidence in newborn/infant care	Birth to 12 months