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

NCT ID: NCT01764958

Last Updated: 2015-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2015-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Premature Birth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

4 Months

Maximum Eligible Age

8 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assuta Hospital Systems

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Orna Lev enacab, BPT

Role: PRINCIPAL_INVESTIGATOR

Assuta Hospital, Tel Aviv

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Maccabi Healthcare services

Naẕerat ‘Illit, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

sponsor

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.