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Clinical Trials/NCT03070158
NCT03070158
Unknown
N/A

Efficacy of a Nursing Intervention in the Mother-premature Infant Affective Bond

Universidad Industrial de Santander3 sites in 1 country148 target enrollmentMay 1, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Premature Infant
Sponsor
Universidad Industrial de Santander
Enrollment
148
Locations
3
Primary Endpoint
Affective bonding score
Last Updated
6 years ago

Overview

Brief Summary

This experimental study will determine the effectiveness of nursing intervention "the attachment promotion" to increase the affective bonds between mothers and their premature infants. The assignment of the mothers to the control group will receive usual care, the mothers will be assigned to intervention group will receive the intervention.

Detailed Description

The premature newborn has a high need for positive interactions, which is a challenge for him, due to biological immaturity, and for his mother because of the level of stress that this situation generates. Behavioral and developmental interventions are needed to address the unique behaviors of preterm infants and the interactive capacities of the mother-newborn premature dyad. The project will be conducted in 18 months. The assignment of the mothers to each group will be like that: First at all, mother will be assignment to control group. They will received usual care when achieve the total of 74 mothers, the mothers will be assigned to intervention group.

Registry
clinicaltrials.gov
Start Date
May 1, 2017
End Date
December 30, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Beatriz Villamizar Carvajal

Principal Investigator

Universidad Industrial de Santander

Eligibility Criteria

Inclusion Criteria

  • Premature Infant:
  • Neonates who had been hospitalized in the neonatal care unit, with ages ranging from 29 - 36.6/7 weeks gestation at birth.
  • Apgar to the minute and five minutes greater to 7/10
  • Mother with nursing diagnosis: Risk of impaired attachment.
  • Mother with a neonate who had hospitalized in the neonatal care unit, with ages ranging from 29 - 36.6/7 weeks of gestation at birth
  • Mother living in the metropolitan perimeter of the city of Bucaramanga

Exclusion Criteria

  • Infants that underwent surgery
  • Infants with neurological injury.
  • Congenital cardiac abnormalities, severe deformities, grade III intraventricular hemorrhage.
  • Mother with limitations: hearing, motor and / or mental handicap-measured through the Abbreviated Mental Test (minimental), that prevent the intervention.
  • Mother consuming psychoactive substances.
  • With mental alterations, verified in the medical history.

Outcomes

Primary Outcomes

Affective bonding score

Time Frame: 1-6 weeks

Changes in the mean score of the nursing outcome: affective bonding measure with the NOC(Nursing Outcomes Classification)

Secondary Outcomes

  • Coping adaptation score(1-6 weeks)

Study Sites (3)

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