At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 100 enrolled

Drug / intervention

Skin-to-Skin contactbehavioral

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00917085

NCT00917085Phase 1Completed

Compare CT.gov

Self-Regulatory Preterm Infant Care: Adaptation Postbirth

National Institute of Nursing Research (NINR)·interventional·Posted Jun 10, 2009·Updated Aug 10, 2009

In Brief

A Phase 1 clinical trial evaluating Skin-to-Skin contact for Moderate to Late Prematurity. Completed, enrolled 100 participants across 2 sites.

Detailed Summary

To see if infant outcomes will improve when mothers are helped to hold their preterm infants skin-to-skin as soon as possible after birth and as often as possible and for as long as possible each time during the next five days.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsModerate to Late Prematurity

CountriesUnited States

Collaborators--

Timeline

Phase 1CompletedFinished

19961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJul 1996

Primary CompletionDec 2001

First PostedJun 2009

TodayJul 2026

First PostedJun 10, 2009

Enrollment StartJul 1, 1996

Primary CompletionDec 1, 2001

TodayJul 2, 2026

Enrollment to primary: 5.4 yearsPosted 17.1 years ago

Interventions

Skin-to-Skin contactbehavioral

Infants in the Skin-to-Skin group also had standard care provided by hospital staff. In addition, the researchers facilitated skin-to-skin contact by placing diaper-clad infants prone between their mothers' breasts as soon as possible after birth. Thereafter the infants and their mothers experienced skin-to-skin contact as often as possible and for as long as possible each time throughout the protocol.