Clinical trial NCT04926402: Kangaroo Care Education Programme (KCEP)
Official title: Effectiveness of Kangaroo Care Education Programme on Mothers, Nurses, and Infants Outcomes in Neonatal Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kangaroo-Mother Care Method
Keywords: Kangaroo Care
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2021-06-15
Enrollment: 96
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline perceptions of KC at 1-month and 3-month among the mothers.
timeFrame: Baseline, 1-month, and 3- month.
measure: Change from baseline knowledge of KC at 1-month and 3-month among the mothers.
timeFrame: Baseline, 1-month, and 3- month.
measure: Change from baseline perceived barrier to KC at 1-month and 3-month among the mothers.
timeFrame: Baseline, 1-month, and 3- month.
measure: Change from baseline perceived stress at 1-month and 3-month among the mothers.
timeFrame: Baseline, 1-month, and 3- month.
measure: Change from baseline weight gain at 1-month and 3 month among infants.
timeFrame: Baseline, 1-month, and 3- month
measure: Change in number of days of hospitalization among the infants.
timeFrame: From day of admission at 28 weeks of gestation until 44 weeks of hospitalization.
measure: Change from baseline breast feeding status at 1-month and 3-month among the infants.
timeFrame: Baseline, 1-month and 3-month
measure: Change from baseline perceptions of KC at 1-month and 3-month among the nurses.
timeFrame: Baseline, 1-month and 3-month
measure: Change from baseline knowledge of KC at 1-month and 3-month among the nurses.
timeFrame: Baseline, 1-month and 3-month
measure: Change from baseline practice of KC at 1-month and 3-month among the nurses.
timeFrame: Baseline, 1-month and 3-month
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
affiliation: University of Malaya
name: Sharmiza Samsudin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.