Kangaroo-Mother Care MethodKCEPNCT04926402
Kangaroo Care Education Programme (KCEP)
A study testing Kangaroo Care Education Program in people with Kangaroo-Mother Care Method, run by University of Malaya at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Kangaroo-Mother Care Method
- What is being tested?
- Kangaroo Care Education Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteMalaysia
- Study dates
- 2 Feb 2018to 30 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Surgical infant i.e cleft lip, cleft palate, spina bifida, exomphalos, and omphalocele.
- Infant required medical treatment eg. prolonged phototherapy treatment.
- Trisomy 21.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 56000
About this study
Official title: Effectiveness of Kangaroo Care Education Programme on Mothers, Nurses, and Infants Outcomes in Neonatal Intensive Care Unit
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.
Read the 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).
- Conditions
- Kangaroo-Mother Care Method
- Being tested
- Kangaroo Care Education Program
- Keywords
- Kangaroo Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo Care Education ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | The control group received standard routine care |
| Kangaroo care education program | Experimental | The experimental group received a maternal kangaroo care education program Receives: Other: Kangaroo Care Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline perceptions of KC at 1-month and 3-month among the mothers.
The respondents were asked to answer 20 items on perceptions of KC. A 5-point Likert scale was used (strongly disagree-1 to strongly agree-5). A lower mean score reflecting a better perception of KC.
Measured: Baseline, 1-month, and 3- month.
Change from baseline knowledge of KC at 1-month and 3-month among the mothers.
The respondents were asked to answer 11 items on knowledge of KC. They were given 'true', 'false', and 'not sure' to indicate their knowledge of KC, with higher mean scores indicating a better level of knowledge
Measured: Baseline, 1-month, and 3- month.
Change from baseline perceived barrier to KC at 1-month and 3-month among the mothers.
The respondents were asked to answer 19 items on perceived barriers to practicing KC. The scale ranged from very influential (5) to not influential at all (1). A lower mean score of perceived barriers means the mothers are very positive.
Measured: Baseline, 1-month, and 3- month.
Change from baseline perceived stress at 1-month and 3-month among the mothers.
The respondents were asked to answer 19 items on perceived stress level. A 5-point Likert scale ranging from not at all stressful (1) to extremely stressful (5), to reflect the level of stress faced by mothers with their premature infant's admission into the NICU. The lower the mean stress scores reported by the mothers, the lower the stress level.
Measured: Baseline, 1-month, and 3- month.
Change from baseline weight gain at 1-month and 3 month among infants.
The infants' weight were measured and recorded.
Measured: Baseline, 1-month, and 3- month
Change in number of days of hospitalization among the infants.
The infants' days of hospitalization were recorded.
Measured: From day of admission at 28 weeks of gestation until 44 weeks of hospitalization.
Change from baseline breast feeding status at 1-month and 3-month among the infants.
The breast feeding status of infants were recorded.
Measured: Baseline, 1-month and 3-month
Change from baseline perceptions of KC at 1-month and 3-month among the nurses.
The respondents were asked to answer 20 items on perceptions of KC. A 5-point Likert scale was used (strongly disagree-1 to strongly agree-5). A lower mean score reflecting a better perception of KC.
Measured: Baseline, 1-month and 3-month
Change from baseline knowledge of KC at 1-month and 3-month among the nurses.
The respondents were asked to answer 11 items on knowledge of KC. They were given 'true', 'false', and 'not sure' to indicate their knowledge of KC, with higher mean scores indicating a better level of knowledge.
Measured: Baseline, 1-month and 3-month
Change from baseline practice of KC at 1-month and 3-month among the nurses.
Respondents were asked to answer 11 items on practice of KC. A 5-point Likert scale. The descriptors were: very uncomfortable (1), somewhat uncomfortable (2), neither comfortable (3), somewhat comfortable (4) and very comfortable (5). A lower mean score indicated a high level of confidence and skills in initiating KC.
Measured: Baseline, 1-month and 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start2 Feb 2018
- Primary completion30 Apr 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Kangaroo-Mother Care MethodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharmiza Samsudin, University of Malaya
- Investigators
- Sharmiza Samsudin, PhD, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926402
- Sponsor's protocol ID
- 201765-5310
- Acronym
- KCEP
- Status last verified
- Jun 2021
- First submitted
- 19 May 2021
- Last updated
- 15 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25422927Conde-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.
PubMed 27552521Cho 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.
PubMed 26975461Davanzo 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.
PubMed 23735714Samsudin 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.
PubMed 37077560
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Kangaroo Care Education Programme on Mothers, Nurses, and Infants Outcomes in Neonatal Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04926402
- Acronym / sponsor ID
- KCEP / 201765-5310
- Conditions
- Kangaroo-Mother Care Method
- Keywords
- Kangaroo Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 15 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –The control group received standard routine care |
| Kangaroo care education program | Experimental | Other: Kangaroo Care Education ProgramThe experimental group received a maternal kangaroo care education program |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Surgical infant i.e cleft lip, cleft palate, spina bifida, exomphalos, and omphalocele.
- Infant required medical treatment eg. prolonged phototherapy treatment.
- Trisomy 21.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kangaroo Care Education ProgramIt 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. | Other | Kangaroo care education program |
Primary outcome
Change from baseline perceptions of KC at 1-month and 3-month among the mothers.
Time frame: Baseline, 1-month, and 3- month.
The respondents were asked to answer 20 items on perceptions of KC. A 5-point Likert scale was used (strongly disagree-1 to strongly agree-5). A lower mean score reflecting a better perception of KC.
Change from baseline knowledge of KC at 1-month and 3-month among the mothers.
Time frame: Baseline, 1-month, and 3- month.
The respondents were asked to answer 11 items on knowledge of KC. They were given 'true', 'false', and 'not sure' to indicate their knowledge of KC, with higher mean scores indicating a better level of knowledge
Change from baseline perceived barrier to KC at 1-month and 3-month among the mothers.
Time frame: Baseline, 1-month, and 3- month.
The respondents were asked to answer 19 items on perceived barriers to practicing KC. The scale ranged from very influential (5) to not influential at all (1). A lower mean score of perceived barriers means the mothers are very positive.
Change from baseline perceived stress at 1-month and 3-month among the mothers.
Time frame: Baseline, 1-month, and 3- month.
The respondents were asked to answer 19 items on perceived stress level. A 5-point Likert scale ranging from not at all stressful (1) to extremely stressful (5), to reflect the level of stress faced by mothers with their premature infant's admission into the NICU. The lower the mean stress scores reported by the mothers, the lower the stress level.
Change from baseline weight gain at 1-month and 3 month among infants.
Time frame: Baseline, 1-month, and 3- month
The infants' weight were measured and recorded.
Change in number of days of hospitalization among the infants.
Time frame: From day of admission at 28 weeks of gestation until 44 weeks of hospitalization.
The infants' days of hospitalization were recorded.
Change from baseline breast feeding status at 1-month and 3-month among the infants.
Time frame: Baseline, 1-month and 3-month
The breast feeding status of infants were recorded.
Change from baseline perceptions of KC at 1-month and 3-month among the nurses.
Time frame: Baseline, 1-month and 3-month
The respondents were asked to answer 20 items on perceptions of KC. A 5-point Likert scale was used (strongly disagree-1 to strongly agree-5). A lower mean score reflecting a better perception of KC.
Change from baseline knowledge of KC at 1-month and 3-month among the nurses.
Time frame: Baseline, 1-month and 3-month
The respondents were asked to answer 11 items on knowledge of KC. They were given 'true', 'false', and 'not sure' to indicate their knowledge of KC, with higher mean scores indicating a better level of knowledge.
Change from baseline practice of KC at 1-month and 3-month among the nurses.
Time frame: Baseline, 1-month and 3-month
Respondents were asked to answer 11 items on practice of KC. A 5-point Likert scale. The descriptors were: very uncomfortable (1), somewhat uncomfortable (2), neither comfortable (3), somewhat comfortable (4) and very comfortable (5). A lower mean score indicated a high level of confidence and skills in initiating KC.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
- Background: PubMed 25422927Cooper 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.
- Background: PubMed 27552521Conde-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.
- Background: PubMed 26975461Cho 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.
- Results publication: PubMed 23735714Davanzo 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.
- Derived from this study: PubMed 37077560Samsudin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharmiza Samsudin, PhD principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kangaroo Care Education Program in people with Kangaroo-Mother Care Method, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline perceptions of KC at 1-month and 3-month among the mothers. (time frame: Baseline, 1-month, and 3- month.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04926402, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2021.