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NCT Number: NCT05565287

Neonatal Neurobehavioral And Motor Behavior In Ultra Early Physical Therapy Intervention

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Neonatal Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Obstetric Labor Complications Obstetric Labor, Premature Parenting Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

PAGNI University Hospital, Heraklion, Crete, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ultra early physiotherapy intervention

Combination Product
  • 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).

Other names: Neurobehavioral Concept (Brazelton), Motor Behavioural Concept (Prechtl)

Primary outcomes

  1. The neonatal behavioural assessment scale (NBAS)

    Time frame: newborn - 2 month old (corrected age)

    Assesses neurobehavioral repertoire of the newborn

  2. The New-born Behavioral Observations (NBO)

    Time frame: 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

  3. The Qualitative Assessment of General Movements (GMsA)

    Time frame: 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

  4. • Karitane Parenting Confidence Scale (KPCS) (Crncec, R., et all., 2008, 2010)

    Time frame: Birth to 12 months

    Assesses perceived parental confidence in newborn/infant care

  5. • Parental Stressor Scale: Neonatal Intensive Care Unit (Pss: Nicu) (Miles, M. S., Funk, S. G., & Carlson, J., 1993)

    Time frame: From Enrollment to the end of interventional 3 months

    Parental Self Reported Questionnaire concerning their experiences in NICU

Secondary outcomes

  1. Parental Stress Scale (PSS-18) (Berry, J., O., & Jones., W., H., 1995)

    Time frame: From enrollment to the end of program at 3 months

    Parental Self Reported Questionnaire concerning their parental experience

Sponsors and collaborators

Lead sponsor

University of Thessaly

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Oct 4, 2022
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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