Neonatal Neurobehavioral And Motor Behavior In Ultra Early Physical Therapy Intervention

University of Thessaly

Status and phase

Active, not recruiting

Early Phase 1

Conditions

Parenting

Neonatal Disease

Premature Birth

Treatments

Combination Product: ultra early physiotherapy intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT05565287

MC10107802620

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

Under 3 months old

Volunteers

Accepts Healthy Volunteers

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