Neonatal Neurobehavioral And Motor Behavior In Ultra Early Physical Therapy Intervention

Not Applicable

• Conditions: Neonatal Disease; Parenting; Premature Birth
• Interventions: Combination Product: ultra early physiotherapy intervention

• Registration Number: NCT05565287
• Lead Sponsor: University of Thessaly

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.

Study Timeline

• Study Start: 2021-03-24
• Study First Submitted: 2022-09-29
• Study First Submitted QC: 2022-09-29
• Study First Posted: 2022-10-04
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-02
• Primary Completion: 2024-09-30
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brazelton and Prechtl Assessment Group	ultra early physiotherapy intervention	Parental advise and intervention based on the combination of neonatal neurobehaviourism (Brazelton) and motor behaviour (Prechtl)

Primary Outcome Measures

Name	Time	Method
The neonatal behavioural assessment scale (NBAS)	newborn - 2 month old (corrected age)	Assesses neurobehavioral repertoire of the newborn
The New-born Behavioral Observations (NBO)	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)	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)	Birth to 12 months	Assesses perceived parental confidence in newborn/infant care

Trial Locations

Locations (1)

Private abd Public Sector; 🇬🇷 Lamia, Greece