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

Premature Birth Clinical Trial

Official title:

Association Between Mother-Infant Attunement During Interaction and the Quality of General Movements and Motor Development of Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01764958
• Other study ID #: sponsor
• Status: Completed
• Phase: N/A
• First received: January 7, 2013
• Last updated: July 7, 2015
• Start date: April 2012
• Est. completion date: June 2015

Study information

• Verified date: April 2012
• Source: Assuta Hospital Systems
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Months to 8 Months

Eligibility

Inclusion Criteria:preterm infants born between 26-34 weeks of gestation, whose mothers speak and write Hebrew fluently.

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Premature Birth

Locations

Country	Name	City	State
Israel	Maccabi Healthcare services	Nazareth Illit

Sponsors (1)

Lead Sponsor	Collaborator
Assuta Hospital Systems

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Better maternal attunement of holding and touch will be associated with better quality of spontaneous movements of the infants.	Infants are videotapes for General Movements Mothers and infants are videotapes for 10 minutes of free interaction	Assesed at 3-4 months corrected age of the infants	No
Secondary	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.	in addition to General Movements and Interaction, developmental milestones will be assessed using the Alberta Infant Motor development Scale.	3-4 months corrected age of the infants	No