NCT01764958

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 8, 2015

Status Verified

April 1, 2012

Enrollment Period

3.2 years

First QC Date

January 7, 2013

Last Update Submit

July 7, 2015

Conditions

Keywords

mother-infant interactiongeneral movementspreterm infants

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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.

    3-4 months corrected age of the infants

Study Arms (1)

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.

Eligibility Criteria

Age4 Months - 8 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maccabi Healthcare services

Naẕerat ‘Illit, Israel

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Orna Lev enacab, BPT

    Assuta Hospital, Tel Aviv

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2013

First Posted

January 10, 2013

Study Start

April 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

July 8, 2015

Record last verified: 2012-04

Locations