NCT00271115

Brief Summary

The primary objective is to determine if kangaroo holding in the first week after birth influences the stress levels of mothers who have delivered their infants prematurely and who require admission to the Special Care Nursery (SCN). Hypothesis: There will be a decrease in maternal stress levels as perceived by mothers and as reflected in their blood pressures and heart rates after kangaroo holding their premature infants in the SCN.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2005

Typical duration 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

September 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 30, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

February 17, 2012

Status Verified

February 1, 2012

Enrollment Period

2.1 years

First QC Date

December 21, 2005

Last Update Submit

February 16, 2012

Conditions

Keywords

Kangaroo holdingKangaroo careMaternal stress levelsPremature birth

Outcome Measures

Primary Outcomes (1)

  • Change in perceived maternal stress after kangaroo holding.

    1 week

Study Arms (1)

Moms w/preterm infants

OTHER

Mothers of preterm infants who are admitted to the newborn intensive care unit.

Behavioral: Kangaroo Holding

Interventions

Mothers will be asked to Kangaroo hold their infants two times during the first week of life.

Moms w/preterm infants

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Mothers:
  • Delivered a premature infant between 30 0/7 and 33 6/7 weeks gestation
  • to 40 years old
  • English speaking
  • Infants:
  • Admitted to Special Care Nursery and on a monitor
  • Medically stable enough to be held (determined by health care team)

You may not qualify if:

  • Mothers:
  • Multiple birth
  • Eclampsia
  • Pre-existing hypertension or at risk (BP above 140/90)
  • Pre-existing cardiac disease
  • HELLP syndrome, or uncontrolled medical condition during pregnancy
  • Use of magnesium sulfate for blood pressure control prior to delivery
  • Known depression or treatment with antidepressants
  • Infants:
  • Congenital anomalies
  • Use of NCPAP or mechanical ventilation
  • medically unstable (as determined by health care team)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christiana Hospital - Special Care Nursery

Newark, Delaware, 19718, United States

Location

Related Publications (3)

  • Affonso D, Bosque E, Wahlberg V, Brady JP. Reconciliation and healing for mothers through skin-to-skin contact provided in an American tertiary level intensive care nursery. Neonatal Netw. 1993 Apr;12(3):25-32.

    PMID: 8474409BACKGROUND
  • Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52.

    PMID: 8506163BACKGROUND
  • Miles MS, Funk SG, Kasper MA. The stress response of mothers and fathers of preterm infants. Res Nurs Health. 1992 Aug;15(4):261-9. doi: 10.1002/nur.4770150405.

    PMID: 1496151BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

  • Karen A. Hall, BSN, RNC

    Christiana Care Health Systems

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2005

First Posted

December 30, 2005

Study Start

September 1, 2005

Primary Completion

October 1, 2007

Study Completion

January 1, 2008

Last Updated

February 17, 2012

Record last verified: 2012-02

Locations