Association Between Mother-Infant Attunement During Interaction and the Quality of General Movements

This study is currently recruiting participants.
Verified April 2012 by Assuta Hospital Systems
Sponsor:
Information provided by (Responsible Party):
Assuta Hospital Systems
ClinicalTrials.gov Identifier:
NCT01764958
First received: January 7, 2013
Last updated: July 7, 2013
Last verified: April 2012
  Purpose

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.


Condition
Preterm Infants

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Association Between Mother-Infant Attunement During Interaction and the Quality of General Movements and Motor Development of Preterm Infants

Resource links provided by NLM:


Further study details as provided by Assuta Hospital Systems:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Infants are videotapes for General Movements Mothers and infants are videotapes for 10 minutes of free interaction


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    in addition to General Movements and Interaction, developmental milestones will be assessed using the Alberta Infant Motor development Scale.


Estimated Enrollment: 60
Study Start Date: April 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.


Detailed Description:

Sixty preterm infants at 3-4 months of corrected age and their mothers will be recruited. Infants will be evaluated for their spontaneous movements and their developmental milestones achievement, and mothers and infants will be evaluated for their attunement during observed interaction, especially on maternal attunement in holding and touching their infants. Mothers will report on demographic background of the family, temperament of their infants and previous Skin to Skin Contact treatment in the Neonatal Intensive Care Unit.

  Eligibility

Ages Eligible for Study:   4 Months to 8 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Preterm infants at a corrected age of 3-4 months and their mothers

Criteria

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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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764958

Locations
Israel
Maccabi Healthcare services Recruiting
Nazareth Illit, Israel
Contact: Orna Lev Enacab, BPT    +972-524548204    levorna26@gmail.com   
Contact: Sarra Beni Shrem, MD    +972-525000051    shrem_s@mac.org.il   
Principal Investigator: Orna Lev_enacab, BPT         
Principal Investigator: Sarra Beni Shrem, MD         
Principal Investigator: Efrat Sher Censor, PHD         
Sub-Investigator: Galia Daube Fishman, BPT         
Sub-Investigator: Christa Einspieler, Proff         
Sponsors and Collaborators
Assuta Hospital Systems
Investigators
Principal Investigator: Orna Lev enacab, BPT Assuta Hospital, Tel Aviv
  More Information

No publications provided

Responsible Party: Assuta Hospital Systems
ClinicalTrials.gov Identifier: NCT01764958     History of Changes
Other Study ID Numbers: sponsor
Study First Received: January 7, 2013
Last Updated: July 7, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by Assuta Hospital Systems:
mother-infant interaction
general movements
preterm infants

ClinicalTrials.gov processed this record on April 17, 2014