Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
96 participants
INTERVENTIONAL
2018-02-02
2019-07-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Simulation-based Low-dose High Frequency (LDHF) Plus Mobile Mentoring (m-Mentoring) Study in Nigeria
NCT03269240
Effect of Educational Program About Preventive Care Bundle for Prevention of Ventilator Associated Pneumonia Among Newborns
NCT06066489
The Effect of Intramuscular Ventrogluteal Injection Training Given by Pecha Kucha Method
NCT06840353
Efficacy of a Multifaceted Intervention to Reduce Medication Administration Errors in Neonatal Intensive Care Units
NCT03036449
Intravenous Fluid Therapy in Hospitals
NCT05964283
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard of care
The control group received standard routine care
No interventions assigned to this group
Kangaroo care education program
The experimental group received a maternal kangaroo care education program
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Both mothers and premature infants were medically and surgically stable.
* Mothers were willing to perform KC and admitted to the NICU.
Exclusion Criteria
* Infant required medical treatment eg. prolonged phototherapy treatment.
* Trisomy 21.
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Malaya
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sharmiza Samsudin
Principle Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sharmiza Samsudin, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Malaya
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, Malaysia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
201765-5310
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.