Neonatal Neurobehavioral And Motor Behavior In Ultra Early Physical Therapy Intervention

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neonatal Disease, Parenting, Premature Birth

Intervention / Treatment
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* Combination Product: ultra early physiotherapy intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: group: Intervention Parental advise based on the combination of neonatal neurobehaviourism and motor behaviour group: Basic hospital guidelines
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brazelton and Prechtl Assessment Group<br>Parental advise and intervention based on the combination of neonatal neurobehaviourism (Brazelton) and motor behaviour (Prechtl) | Combination Product: ultra early physiotherapy intervention<br>* 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).<br>* Other names: Motor Behavioural Concept (Prechtl);|
| No Intervention: No intervention group<br>Basic hospital guidelines | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Assesses perceived parental confidence in newborn/infant care | Birth to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prematurity, subsystem organization, motor system, state system, general movements, spontaneous mobility, parental confidence, neonatal neurobehavior