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Clinical Trials/NCT04908332
NCT04908332CompletedNot Applicable

Effect of a Nursing Intervention on the Mother-baby Kangaroo Interaction at Home in Bogotá

Universidad Nacional de Colombia1 site in 1 country68 target enrollmentStarted: July 22, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
68
Locations
1
Primary Endpoint
weight

Study Overview

Brief Summary

The objective of this randomized clinical trial will determine the effectiveness of nursing intervention (Kangaroo Baby Massage) on the interaction between mothers and premature, low birth weight infants at home The dyad mother- infant of the control group will receive Kangaroo position KP and the dyad mother- infant mothers of the intervention group will receive the Kangaroo Baby Massage KBM

Detailed Description

Participants and methods: 68 dyads mother-infant will randomize, 34 in intervention KBM group and 34 in control group KP, previous they meet inclusion criteria and accept their participation through informed consent. weight gain and Kangaroo position days at home will be the primaries outcomes. The Alert states, Types of BC feeding, Perceived maternal parental self-efficacy and Postnatal depression. Will be secondary outcomes.

Barnard's mother-child interaction theory supports the study

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description

The infant-mother dyads will not be Know that there are two different interventions in each group. This leads to greater adherence to treatment.

The researchers: there will be two research assistants who will receive capacity regardless of the group of participants they are going to train, the main researcher will not carry out the training to the mothers and will be blinded.

The nursing assistant in charge of weighing the baby and the pediatrician who determines the time of the kangaroo position. They will be blinded.

Eligibility Criteria

Ages
2 Days to 3 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Prematures and low birth weight infants in Kangaroo position with a chronological age less than 3 months
  • •The mothers take care the infant at home
  • •Baby with a weight equal to or greater than 1800 grams at the time of entry to the study.
  • •Baby whose birth was institutional or extra-institutional.
  • •Mothers with training in the Kangaroo Mother Program
  • •Children controlled in the Ambulatory Kangaroo Mother Program

Exclusion Criteria

  • •Children diagnosed with intraventricular hemorrhages grade III and IV or congenital malformations
  • •Children who have more than one ambulatory kangaroo control
  • •Children who have been at home for more than 3 days without starting the ambulatory kangaroo control
  • •Babies with infections and other pathologies that require hospitalization during the study
  • •Presence of infectious diseases and other pathologies in the mother that require hospitalization
  • •Mother confirmed with positive test for covid 19 at the moment of the randomization
  • •Mothers with cognitive problems or mental disorders.

Arms & Interventions

Kangaroo baby Massage

Experimental

The mother will apply the massage. The baby kangaroo will be exposed to the KBM for 10 minutes once a day during the time that the infant need to stay in kangaroo position at home. If the baby wakes up and wants to eat the KBM will be interrupted immediately and the baby will be fed, The temperature will be measured before and after the intervention. The massage will begin 60 minutes after the feed.

Intervention: Kangaroo Baby Massage (Behavioral)

Kangaroo position

Active Comparator

The infant must be in Kangaroo position with the mother semi sitting on bed with elevation of at least 30 degrees during 10 minutes every day until the infant doesn´t need to stay in kangaroo position at home.The temperature will be measured 60 minutes after the feed and 10 minutes after KP. If the baby wakes up and wants to eat the KP will be interrupted immediately and the baby will be fed, then the KP will be completed of time ( 10 minutes) to measure the temperature.

Intervention: Kangaroo Baby Massage (Behavioral)

Outcomes

Primary Outcomes

weight

Time Frame: Through study completion, an average of 20 days

Weight gain after randomization up to infant doesn´t need to stay in kangaroo position at home.

Kangaroo position days at home

Time Frame: Through study completion, an average of 20 days

Number days that the infant needs to stay in kangaroo position at home

Secondary Outcomes

  • Alert states(Through study completion, an average of 20 days)
  • Types of feeding(Through study completion, an average of 20 days)
  • Perceived maternal parental self-efficacy(Given by a self-report provided by the mother of the perceived maternal parental self-efficacy questionnaire on day 1 before randomization and day 7 and 14 after randomization)
  • Postnatal depression(Given by a self-report provided by the mother of the Edinburgh Postnatal Depression Scale on day 1 before randomization and day 7 and 14 after randomization)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nubia Castiblanco Lopez

student Nursing PhD

Universidad Nacional de Colombia

Study Sites (1)

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