- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01764958
Association Between Mother-Infant Attunement During Interaction and the Quality of General Movements
Association Between Mother-Infant Attunement During Interaction and the Quality of General Movements and Motor Development of Preterm Infants
The proposed research has the potential of contributing to the limited empirical literature on the relationship between maternal sensitivity and motor development of preterm infants. If indeed maternal attuned behaviors will be found to be associated with the quality of motor development, such a finding will support the effectiveness of physical therapy in guiding caregivers to attune their holding and touch of preterm infants.
We hypothesize that mothers and infants' attunement during observed interaction will be related to the quality of preterm infants' spontaneous movements in the following ways: First, better maternal attunement to the infants needs, and in particular attunement of holding and touch will be associated with better quality of spontaneous movements of the infants. Second, more initiations and/or involvement of infants in interaction will be associated with better maternal attunement to the infant. Third, more initiations and/or involvement of infants in interaction will be associated with better quality of spontaneous movements and better achievements in developmental milestone. All hypotheses will be examined while controlling for maternal use of SSC method during hospitalization after birth and family demographic backgrounds.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Nazareth Illit, Israel
- Maccabi Healthcare Services
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:preterm infants born between 26-34 weeks of gestation, whose mothers speak and write Hebrew fluently.
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Exclusion Criteria:preterm infants who suffer from perinatal asphyxia, genetic or metabolic diseases, necrotizing colitis that requires operation, intra uterine growth retardation, deafness, retinopathy of prematurity (ROP) or major congenital defects.
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Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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preterm infants and their mothers
Inclusion criteria are: preterm infants born between 26-34 weeks of gestation, whose mothers speak and write Hebrew fluently. Exclusion criteria are: preterm infants who suffer from perinatal asphyxia, genetic or metabolic diseases, necrotizing colitis that requires operation, intra uterine growth retardation, deafness, retinopathy of prematurity (ROP) or major congenital defects. Infants and their mothers will be recruited from child developmental centers and Pediatric Clinics of Maccabi. No intervention is included in the research. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Better maternal attunement of holding and touch will be associated with better quality of spontaneous movements of the infants.
Time Frame: Assesed at 3-4 months corrected age of the infants
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Infants are videotapes for General Movements Mothers and infants are videotapes for 10 minutes of free interaction
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Assesed at 3-4 months corrected age of the infants
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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More initiations and/or involvement of infants during the interaction will be associated with better quality of spontaneous movements of the infants and better achievement in developmental milestones.
Time Frame: 3-4 months corrected age of the infants
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in addition to General Movements and Interaction, developmental milestones will be assessed using the Alberta Infant Motor development Scale.
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3-4 months corrected age of the infants
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Orna Lev enacab, BPT, Assuta Hospital, Tel Aviv
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sponsor (Other Grant/Funding Number: Sponsor)
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