---
title: Neonatal Neurobehavioral And Motor Behavior In Ultra Early Physical Therapy Intervention
nct_id: NCT05565287
overall_status: ACTIVE_NOT_RECRUITING
phase: EARLY_PHASE1
sponsor: University of Thessaly
study_type: INTERVENTIONAL
primary_condition: Neonatal Disease
countries: Greece
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05565287.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05565287"
ct_last_update_post_date: 2025-06-17
last_seen_at: "2026-05-12T06:38:33.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Neonatal Neurobehavioral And Motor Behavior In Ultra Early Physical Therapy Intervention

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

**NCT ID:** [NCT05565287](https://clinicaltrials.gov/study/NCT05565287)

## Key Facts

- **Status:** ACTIVE_NOT_RECRUITING
- **Phase:** EARLY_PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 80
- **Lead Sponsor:** University of Thessaly
- **Conditions:** Neonatal Disease, Parenting, Premature Birth
- **Start Date:** 2021-09-24
- **Completion Date:** 2025-12-30
- **CT.gov Last Update:** 2025-06-17

## 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.

## Eligibility

- **Maximum age:** 3 Months
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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
```

## Arms

- **Brazelton and Prechtl Assessment Group** (EXPERIMENTAL) — Parental advise and intervention based on the combination of neonatal neurobehaviourism (Brazelton) and motor behaviour (Prechtl)
- **No intervention group** (NO_INTERVENTION) — Basic hospital guidelines

## Interventions

- **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).

## Primary Outcomes

- **The neonatal behavioural assessment scale (NBAS)** _(time frame: newborn - 2 month old (corrected age))_ — Assesses neurobehavioral repertoire of the newborn
- **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
- **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
- **• 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
- **• 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

- **Parental Stress Scale (PSS-18) (Berry, J., O., & Jones., W., H., 1995)** _(time frame: From enrollment to the end of program at 3 months)_

## Locations (3)

- PAGNI University Hospital, Heraklion, Crete, Greece
- Attikon Hospital, Athens, Haidari, Greece
- University of Thessaly, Lamia, Greece

## Recent Field Changes (last 30 days)

- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.pagni university hospital|heraklion|crete|greece` — added _(2026-05-12)_
- `locations.attikon hospital|athens|haidari|greece` — added _(2026-05-12)_
- `locations.university of thessaly|lamia||greece` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_

---

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