NCT01121523

Brief Summary

The present study is an examination of cue-directed tactile stimulation (CTDS), administered by mothers and NICU nurses, on infant and maternal stress reactivity, infant immune system functioning, maternal parenting cognitions, and parenting competence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

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

January 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2010

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

October 21, 2015

Status Verified

October 1, 2015

Enrollment Period

3.9 years

First QC Date

May 10, 2010

Last Update Submit

October 19, 2015

Conditions

Premature; Infant, Light-for-dates

Keywords

Prematuritymassagestressparentinginfancysleepintervention

Outcome Measures

Primary Outcomes (1)

  • Stress reactivity

    Infant and maternal salivary cortisol

    one month post-intervention

Secondary Outcomes (1)

  • Infant immune functioning

    2-3 months post-intervention

Study Arms (2)

Cue-directed tactile stimulation

EXPERIMENTAL
Behavioral: Cue directed tactile stimulation

Control group

ACTIVE COMPARATOR
Behavioral: Cue directed tactile stimulation

Interventions

Cue directed tactile stimulationBEHAVIORAL

Cue-based tactile stimulation delivered to medically stable premature infants three times daily by mothers or trained NICU nurses daily for 4 consecutive weeks

Also known as: Massage
Control groupCue-directed tactile stimulation

Eligibility Criteria

Age7 Days - 4 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may not qualify if:

  • The following babies will be excluded:
  • With any chromosomal abnormality
  • With congenital heart disease
  • With any surgical intervention
  • With intraventricular hemorrhages greater than grade II
  • If mother dies during delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Hershey Children's Hospital

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Massage

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Douglas M Teti, Ph.D.

    The Pennsylvania State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Human Development

Study Record Dates

First Submitted

May 10, 2010

First Posted

May 12, 2010

Study Start

January 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

October 21, 2015

Record last verified: 2015-10

Locations

US(1)