Kangaroo Care Education Programme (KCEP)

NCT ID: NCT04926402

Last Updated: 2021-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-02

Study Completion Date

2019-07-30

Brief Summary

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A quasi-experimental and longitudinal study was conducted to evaluate the effectiveness of the kangaroo care education program (KCEP) on Mothers, Nurses, and Infants Outcomes in a Neonatal Intensive Care Unit. Forty-eight mother-infant dyads were enrolled per arm in the control and experimental groups. The control group received standard routine care, while the experimental group received a maternal kangaroo care education program.

Detailed Description

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Introduction:

Kangaroo care (KC) is a simple, low cost and highly effective evidence-based nursing intervention that can benefit from mother-infant bonding attachment. Most mothers of premature infants will experience stress being separated from their premature infants. Bonding with premature infants will develop their brain and also make them feel loved, safe, and secure. Therefore, KC will help in bonding attachment, increase weight gain, decrease hospitalization, and increase breastfeeding rates.

Aim:

This study aims to investigate the effectiveness of two programs; a nursing education program and a mother education program regarding KC techniques on mothers, nurses, and infant outcomes.

Method:

A combination of two designs: Quasi-experimental and longitudinal designs with self-administered questionnaires were carried out to evaluate mothers, nurses, and infant outcomes using the Kangaroo Care Questionnaires Survey (KCQs) and Parental Stressor Scale: Neonatal Intensive Care Unit, Parental and Relationship (PSS: NICU: P\&R) at a neonatal intensive care unit (NICU) of a Malaysian teaching hospital in Klang Valley. The kangaroo care education program (KC-EP) included theoretical and practical sessions on the KC benefits and hands-on KC techniques. The study consisted of three phases: Phase I (n=48 mother-infants dyads) in the control group, Phase II (n=47 nurses - KC-EP), and Phase III (n=48 mother-infants dyads-KC-EP) in the experimental group. Data collection for mothers and infants occurred at various time points during the study; pre-intervention (T0) post - 1-month intervention (T1) and post - 3-month intervention (T2). For the nursing outcomes occurred before and after the 7th day of the intervention program. The results were analyzed using the Statistical Package of Social Sciences(SPSS) version 23. Descriptive statistics were used to analyze the demographic data and items of the questionnaire. GLM univariate and repeated measure analysis of variance (RM-ANOVA) followed by Bonferroni test for mean comparison between control and experimental groups at (T0, T1, and T2).

Conditions

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Kangaroo-Mother Care Method

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Standard of care

The control group received standard routine care

Group Type NO_INTERVENTION

No interventions assigned to this group

Kangaroo care education program

The experimental group received a maternal kangaroo care education program

Group Type EXPERIMENTAL

Kangaroo Care Education Program

Intervention Type OTHER

It is a special method of caring for a premature infant in which the baby is positioned for at least 1 hour a day in an upright skin-to-skin and chest-to-chest contact with its mother.

Interventions

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Kangaroo Care Education Program

It is a special method of caring for a premature infant in which the baby is positioned for at least 1 hour a day in an upright skin-to-skin and chest-to-chest contact with its mother.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Premature infant at corrected age between 28 weeks to 36+6 weeks gestation.
* Both mothers and premature infants were medically and surgically stable.
* Mothers were willing to perform KC and admitted to the NICU.

Exclusion Criteria

* Surgical infant i.e cleft lip, cleft palate, spina bifida, exomphalos, and omphalocele.
* Infant required medical treatment eg. prolonged phototherapy treatment.
* Trisomy 21.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Malaya

OTHER

Sponsor Role lead

Responsible Party

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Sharmiza Samsudin

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sharmiza Samsudin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Malaya

Locations

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University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, Malaysia

Site Status

Countries

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Malaysia

References

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Cooper L, Morrill A, Russell RB, Gooding JS, Miller L, Berns SD. Close to me: enhancing kangaroo care practice for NICU staff and parents. Adv Neonatal Care. 2014 Dec;14(6):410-23. doi: 10.1097/ANC.0000000000000144.

Reference Type BACKGROUND
PMID: 25422927 (View on PubMed)

Conde-Agudelo A, Diaz-Rossello JL. Kangaroo mother care to reduce morbidity and mortality in low birthweight infants. Cochrane Database Syst Rev. 2016 Aug 23;2016(8):CD002771. doi: 10.1002/14651858.CD002771.pub4.

Reference Type BACKGROUND
PMID: 27552521 (View on PubMed)

Cho ES, Kim SJ, Kwon MS, Cho H, Kim EH, Jun EM, Lee S. The Effects of Kangaroo Care in the Neonatal Intensive Care Unit on the Physiological Functions of Preterm Infants, Maternal-Infant Attachment, and Maternal Stress. J Pediatr Nurs. 2016 Jul-Aug;31(4):430-8. doi: 10.1016/j.pedn.2016.02.007. Epub 2016 Mar 11.

Reference Type BACKGROUND
PMID: 26975461 (View on PubMed)

Davanzo R, Brovedani P, Travan L, Kennedy J, Crocetta A, Sanesi C, Strajn T, De Cunto A. Intermittent kangaroo mother care: a NICU protocol. J Hum Lact. 2013 Aug;29(3):332-8. doi: 10.1177/0890334413489375. Epub 2013 Jun 4.

Reference Type RESULT
PMID: 23735714 (View on PubMed)

Samsudin S, Chui PL, Ahmad Kamar A, Abdullah KL, Yu CW, Mohamed Z. The Impact of Structured Kangaroo Care Education on Premature Infants' Weight Gain, Breastfeeding and Length of Hospitalization in Malaysia. J Multidiscip Healthc. 2023 Apr 12;16:1023-1035. doi: 10.2147/JMDH.S403206. eCollection 2023.

Reference Type DERIVED
PMID: 37077560 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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201765-5310

Identifier Type: -

Identifier Source: org_study_id

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