Neonatal Neurobehavioral And Motor Behavior In Ultra Early Physical Therapy Intervention
Primary Purpose
Neonatal Disease, Parenting, Premature Birth
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
ultra early physiotherapy intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Neonatal Disease focused on measuring prematurity, subsystem organization, motor system, state system, general movements, spontaneous mobility, parental confidence, neonatal neurobehavior
Eligibility Criteria
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
Sites / Locations
- Private abd Public Sector
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Brazelton and Prechtl Assessment Group
No intervention group
Arm Description
Parental advise and intervention based on the combination of neonatal neurobehaviourism (Brazelton) and motor behaviour (Prechtl)
Basic hospital guidelines
Outcomes
Primary Outcome Measures
The neonatal behavioural assessment scale (NBAS)
Assesses neurobehavioral repertoire of the newborn
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
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
Karitane Parenting Confidence scale (KPCS)
Assesses perceived parental confidence in newborn/infant care
Secondary Outcome Measures
Full Information
NCT ID
NCT05565287
First Posted
September 29, 2022
Last Updated
November 1, 2022
Sponsor
University of Thessaly
1. Study Identification
Unique Protocol Identification Number
NCT05565287
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 24, 2021 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
March 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Thessaly
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Disease, Parenting, Premature Birth
Keywords
prematurity, subsystem organization, motor system, state system, general movements, spontaneous mobility, parental confidence, neonatal neurobehavior
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
group: Intervention Parental advise based on the combination of neonatal neurobehaviourism and motor behaviour
group: Basic hospital guidelines
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
prematurity (NICU)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Brazelton and Prechtl Assessment Group
Arm Type
Experimental
Arm Description
Parental advise and intervention based on the combination of neonatal neurobehaviourism (Brazelton) and motor behaviour (Prechtl)
Arm Title
No intervention group
Arm Type
No Intervention
Arm Description
Basic hospital guidelines
Intervention Type
Combination Product
Intervention Name(s)
ultra early physiotherapy intervention
Other Intervention Name(s)
Neurobehavioral Concept (Brazelton), Motor Behavioural Concept (Prechtl)
Intervention Description
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 Outcome Measure Information:
Title
The neonatal behavioural assessment scale (NBAS)
Description
Assesses neurobehavioral repertoire of the newborn
Time Frame
newborn - 2 month old (corrected age)
Title
The New-born Behavioral Observations (NBO)
Description
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
Time Frame
Βirth through the 3rd month of life
Title
The Qualitative Assessment of General Movements (GMsA)
Description
non-invasive and non-disruptive assessment through observations of the quality of generalised movements to determine the integrity of the CNS of infants
Time Frame
birth to 20 weeks (corrected age)
Title
Karitane Parenting Confidence scale (KPCS)
Description
Assesses perceived parental confidence in newborn/infant care
Time Frame
Birth to 12 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Panagiotis N Triggas
Organizational Affiliation
University of Thessaly
Official's Role
Study Director
Facility Information:
Facility Name
Private abd Public Sector
City
Lamia
ZIP/Postal Code
35100
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
853137
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
1420621
Citation
Volpe JJ. Brain injury in the premature infant--current concepts of pathogenesis and prevention. Biol Neonate. 1992;62(4):231-42. doi: 10.1159/000243876.
Results Reference
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PubMed Identifier
2253578
Citation
Prechtl HF. Qualitative changes of spontaneous movements in fetus and preterm infant are a marker of neurological dysfunction. Early Hum Dev. 1990 Sep;23(3):151-8. doi: 10.1016/0378-3782(90)90011-7. No abstract available.
Results Reference
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PubMed Identifier
3905347
Citation
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Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
Aita M, Stremler R, Feeley N, Lavallee A, De Clifford-Faugere G. Effectiveness of interventions during NICU hospitalization on the neurodevelopment of preterm infants: a systematic review protocol. Syst Rev. 2017 Nov 3;6(1):225. doi: 10.1186/s13643-017-0613-5.
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Malak R, Fechner B, Sikorska D, Rosolek M, Mojs E, Samborski W, Baum E. Application of the Neonatal Behavioral Assessment Scale to Evaluate the Neurobehavior of Preterm Neonates. Brain Sci. 2021 Sep 28;11(10):1285. doi: 10.3390/brainsci11101285.
Results Reference
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Citation
Aita M, De Clifford Faugere G, Lavallee A, Feeley N, Stremler R, Rioux E, Proulx MH. Effectiveness of interventions on early neurodevelopment of preterm infants: a systematic review and meta-analysis. BMC Pediatr. 2021 Apr 29;21(1):210. doi: 10.1186/s12887-021-02559-6.
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Neonatal Neurobehavioral And Motor Behavior In Ultra Early Physical Therapy Intervention
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