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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00271115
Other study ID # 25165
Secondary ID
Status Completed
Phase N/A
First received December 21, 2005
Last updated February 16, 2012
Start date September 2005
Est. completion date January 2008

Study information

Verified date February 2012
Source Christiana Care Health Services
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Description:

This study builds on known observations by previous researchers that the birth and hospitalization of premature infants creates stressful events in the lives of parents (Shields-Poe & Pinelli, 1997). The challenge for health care workers is to provide for the physical and psychological needs of infants within a highly technological setting such as the SCN. It is necessary to facilitate effective bonding between parents and infants. Effective bonding is linked with successful parenting role development. Stress can alter the development of a positive parental role.

Kangaroo holding, or skin-to-skin holding, involves placing a diaper clad infant vertical and prone between a mother's breasts (Affonso, 1993). As evidenced by the literature, stress can have an altering effect on the maternal attachment role psychologically and place physical demands on the cardiovascular system. Kangaroo care is one variable that may change the perception of maternal stress during preterm hospitalization by assisting mothers to gain control of the parental role, permitting maternal bonding and reducing maternal separation as well as potentially decreasing the allostatic load as associated with physiologic stress.

This study will compare maternal perceived stress levels before and after kangaroo holding during the first week of life. Mothers who are enrolled in this study will be asked to Kangaroo hold their infants at least two times during the first week of life. The first kangaroo hold will take place with the first 48 hours of life. The second kangaroo hold will take place between day of life five and seven. Mothers may kangaroo hold their infants more than two times, however this study will only examine the kangaroo holding sessions that take place at the two times specified above. This study includes both physiologic and psychologic measurements. Mothers will have their blood pressure and heart rate measured before and after each of the two kangaroo holding sessions. These mothers will also be asked to complete a self-report stress inventory scale prior to the first kangaroo holding session (first 48 hours of infant's life) and again after the second kangaroo holding session (infant's day of life five to seven).


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date January 2008
Est. primary completion date October 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

Mothers:

- Delivered a premature infant between 30 0/7 and 33 6/7 weeks gestation

- 20 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)

Exclusion Criteria:

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Christiana Hospital - Special Care Nursery Newark Delaware

Sponsors (1)

Lead Sponsor Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in perceived maternal stress after kangaroo holding. 1 week No
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