Kangaroo-Mother CareNCT06707376
Early Kangaroo Care vs. Standard Neonatal Practices: Impact on Survival and Outcomes in Preterm Infants
A study testing Early Kangaroo Mother Care in people with Kangaroo-Mother Care and Preterm Infants, run by Jouf University at 1 site in Egypt.
Trial summary
This study aims to evaluate the efficacy of Early Kangaroo Mother Care (KMC) compared to standard neonatal nursing practices in improving survival rates and nursing outcomes among preterm infants weighing less than 2000 grams with mild to moderate respiratory distress. Read more about this study
- Who is it for?
- Ages 28 to 36 weeks
- Conditions the study is for
- Kangaroo-Mother Care, Preterm Infants
- What is being tested?
- Early Kangaroo Mother Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Jan 2025
- 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 28 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants born at <37 weeks of gestation.
- Birth weight <2000 grams.
- Diagnosed with mild to moderate respiratory distress (based on clinical criteria such as respiratory rate, oxygen saturation levels, and need for respiratory support).
Who cannot join
- Infants with severe respiratory distress requiring mechanical ventilation.
- Infants with congenital anomalies or other significant health issues.
- Mothers unable or unwilling to provide KMC (e.g., due to medical conditions, lack of willingness).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Kangaroo Mother Care Versus Standard Neonatal Nursing Practices: A Randomized Controlled Trial on Survival and Nursing Outcomes in Preterm Infants (<2000 g) With Mild to Moderate Respiratory Distress
This study aims to evaluate the efficacy of Early Kangaroo Mother Care (KMC) compared to standard neonatal nursing practices in improving survival rates and nursing outcomes among preterm infants weighing less than 2000 grams with mild to moderate respiratory distress. Utilizing a randomized controlled trial design, the research will be conducted in neonatal intensive care units (NICUs) across selected hospitals. Primary outcomes include infant survival rates, incidence of complications, and measures of maternal-infant bonding. Secondary outcomes involve nursing practices, caregiver satisfaction, and long-term developmental milestones. The use of validated, free assessment tools will ensure reliability and accessibility. Findings from this study are expected to inform best practices in neonatal care, potentially leading to improved health outcomes for preterm infants.
Read the detailed description
Preterm birth, defined as delivery before 37 weeks of gestation, is a leading cause of neonatal morbidity and mortality worldwide. Infants weighing less than 2000 grams are particularly vulnerable to complications, including respiratory distress syndrome (RDS), which can significantly impact survival rates and long-term development. Traditional neonatal nursing practices focus on providing respiratory support, maintaining body temperature, and ensuring adequate nutrition. However, emerging evidence suggests that Kangaroo Mother Care (KMC), which emphasizes skin-to-skin contact and exclusive breastfeeding, may offer superior outcomes for preterm infants.
Kangaroo Mother Care (KMC) KMC involves continuous skin-to-skin contact between the mother and infant, promoting thermal regulation, enhancing breastfeeding, and fostering maternal-infant bonding. Studies have indicated that KMC can reduce mortality rates, lower the incidence of infections, and improve neurodevelopmental outcomes. Despite its benefits, the implementation of KMC varies across healthcare settings, and its comparative effectiveness against standard neonatal care practices warrants further investigation.
Objectives
- To compare the survival rates of preterm infants (<2000 g) with mild to moderate respiratory distress receiving early KMC versus standard neonatal nursing practices.
- To evaluate the impact of early KMC on nursing outcomes, including maternal-infant bonding and breastfeeding rates.
- To assess the feasibility and acceptability of implementing early KMC in NICUs.
- Conditions
- Kangaroo-Mother Care, Preterm Infants
- Being tested
- Early Kangaroo Mother Care
- Keywords
- Kangaroo-Mother Care, Neonatal Nursing Practices, Preterm Infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Kangaroo Mother CareOther
- Initiation of KMC within 24 hours of birth.
- Continuous skin-to-skin contact for at least 8 hours per day, with gradual increase based on infant tolerance.
- Support for exclusive breastfeeding or expressed breast milk feeding.
- Ongoing assessment and support from trained neonatal nurses and lactation consultants.
| Study group | Role | What they receive |
|---|---|---|
| Early Kangaroo Mother Care Group | Experimental | Early Kangaroo Mother Care Group:
* Initiation of KMC within 24 hours of birth.
* Continuous skin-to-skin contact for at least 8 hours per day, with gradual increase based on infant tolerance.
* Support for exclusive breastfeeding or expressed breast milk feeding.
* Ongoing assessment and support from trained neonatal nurses and lactation consultants. Receives: Other: Early Kangaroo Mother Care |
| Control Group | No intervention | Control Group: * Standard neonatal nursing practices, including incubator care, intermittent holding, and feeding as per clinical guidelines. * Respiratory support as needed based on the severity of respiratory distress. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Rates
Survival Rates will be the proportion of preterm infants who survive following the implementation of KMC, a practice emphasizing continuous skin-to-skin contact and exclusive breastfeeding.
For infants weighing less than 2000 grams, KMC has been associated with reduced mortality, particularly in low-resource settings where conventional neonatal care may be limited. By promoting physiological stability, enhancing maternal bonding, and reducing the risk of severe complications like infections and hypothermia, KMC offers a cost-effective and impactful approach to improving survival outcomes in this vulnerable population.
Measured: Up to 24 weeks
Incidence of Complications
Incidence of Complications Including infections, intraventricular hemorrhage, and necrotizing enterocolitis.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 Jan 2023
- Primary completion30 Jun 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kangaroo-Mother CareStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Early Kangaroo Mother Care Group: * Initiation of KMC within 24 hours of birth. * Continuous skin-to-skin contact for at least 8 hours per day, with gradual increase based on infant tolerance. * Support for exclusive breastfeeding or expressed breast milk feeding. * Ongoing assessment and support from trained neonatal nurses and lactation consultants. Control Group: * Standard neonatal nursing practices, including incubator care, intermittent holding, and feeding as per clinical guidelines. * Respiratory support as needed based on the severity of respiratory distress.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jouf University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadia Elsharkawy, Jouf University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707376
- Sponsor's protocol ID
- 547-10-2024
- Status last verified
- Feb 2025
- First submitted
- 20 Nov 2024
- Last updated
- 25 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ramadan OME, Alshammari AM, Alruwaili AN, Elsharkawy NB, Alhaiti A, Baraka NIM. Transforming neonatal nursing: a randomized controlled trial comparing kangaroo care and standard protocols for survival in preterm infants with respiratory distress syndrome. BMC Nurs. 2025 Apr 16;24(1):430. doi: 10.1186/s12912-025-03088-8.
PubMed 40241073
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Kangaroo Mother Care Versus Standard Neonatal Nursing Practices: A Randomized Controlled Trial on Survival and Nursing Outcomes in Preterm Infants (<2000 g) With Mild to Moderate Respiratory Distress
- ClinicalTrials.gov ID
- NCT06707376
- Acronym / sponsor ID
- 547-10-2024
- Conditions
- Kangaroo-Mother Care, Preterm Infants
- Keywords
- Kangaroo-Mother Care, Neonatal Nursing Practices, Preterm Infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Jouf UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 27 Nov 2024 (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.
This study aims to evaluate the efficacy of Early Kangaroo Mother Care (KMC) compared to standard neonatal nursing practices in improving survival rates and nursing outcomes among preterm infants weighing less than 2000 grams with mild to moderate respiratory distress. Utilizing a randomized controlled trial design, the research will be conducted in neonatal intensive care units (NICUs) across selected hospitals. Primary outcomes include infant survival rates, incidence of complications, and measures of maternal-infant bonding. Secondary outcomes involve nursing practices, caregiver satisfaction, and long-term developmental milestones. The use of validated, free assessment tools will ensure reliability and accessibility. Findings from this study are expected to inform best practices in neonatal care, potentially leading to improved health outcomes for preterm infants.
Detailed description
Preterm birth, defined as delivery before 37 weeks of gestation, is a leading cause of neonatal morbidity and mortality worldwide. Infants weighing less than 2000 grams are particularly vulnerable to complications, including respiratory distress syndrome (RDS), which can significantly impact survival rates and long-term development. Traditional neonatal nursing practices focus on providing respiratory support, maintaining body temperature, and ensuring adequate nutrition. However, emerging evidence suggests that Kangaroo Mother Care (KMC), which emphasizes skin-to-skin contact and exclusive breastfeeding, may offer superior outcomes for preterm infants.
Kangaroo Mother Care (KMC) KMC involves continuous skin-to-skin contact between the mother and infant, promoting thermal regulation, enhancing breastfeeding, and fostering maternal-infant bonding. Studies have indicated that KMC can reduce mortality rates, lower the incidence of infections, and improve neurodevelopmental outcomes. Despite its benefits, the implementation of KMC varies across healthcare settings, and its comparative effectiveness against standard neonatal care practices warrants further investigation.
Objectives
- To compare the survival rates of preterm infants (<2000 g) with mild to moderate respiratory distress receiving early KMC versus standard neonatal nursing practices.
- To evaluate the impact of early KMC on nursing outcomes, including maternal-infant bonding and breastfeeding rates.
- To assess the feasibility and acceptability of implementing early KMC in NICUs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Early Kangaroo Mother Care Group: * Initiation of KMC within 24 hours of birth. * Continuous skin-to-skin contact for at least 8 hours per day, with gradual increase based on infant tolerance. * Support for exclusive breastfeeding or expressed breast milk feeding. * Ongoing assessment and support from trained neonatal nurses and lactation consultants. Control Group: * Standard neonatal nursing practices, including incubator care, intermittent holding, and feeding as per clinical guidelines. * Respiratory support as needed based on the severity of respiratory distress.
| Arm | Type | Receives |
|---|---|---|
| Early Kangaroo Mother Care Group | Experimental | Other: Early Kangaroo Mother CareEarly Kangaroo Mother Care Group: * Initiation of KMC within 24 hours of birth. * Continuous skin-to-skin contact for at least 8 hours per day, with gradual increase based on infant tolerance. * Support for exclusive breastfeeding or expressed breast milk feeding. * Ongoing assessment and support from trained neonatal nurses and lactation consultants. |
| Control Group | No intervention | –Control Group: * Standard neonatal nursing practices, including incubator care, intermittent holding, and feeding as per clinical guidelines. * Respiratory support as needed based on the severity of respiratory distress. |
Who may qualify
- Ages
- 28 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm infants born at <37 weeks of gestation.
- Birth weight <2000 grams.
- Diagnosed with mild to moderate respiratory distress (based on clinical criteria such as respiratory rate, oxygen saturation levels, and need for respiratory support).
Key exclusion criteria (3 listed)
- Infants with severe respiratory distress requiring mechanical ventilation.
- Infants with congenital anomalies or other significant health issues.
- Mothers unable or unwilling to provide KMC (e.g., due to medical conditions, lack of willingness).
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 |
|---|---|---|
| Early Kangaroo Mother Care* Initiation of KMC within 24 hours of birth. * Continuous skin-to-skin contact for at least 8 hours per day, with gradual increase based on infant tolerance. * Support for exclusive breastfeeding or expressed breast milk feeding. * Ongoing assessment and support from trained neonatal nurses and lactation consultants. | Other | Early Kangaroo Mother Care Group |
Primary outcome
Survival Rates
Time frame: Up to 24 weeks
Survival Rates will be the proportion of preterm infants who survive following the implementation of KMC, a practice emphasizing continuous skin-to-skin contact and exclusive breastfeeding. For infants weighing less than 2000 grams, KMC has been associated with reduced mortality, particularly in low-resource settings where conventional neonatal care may be limited. By promoting physiological stability, enhancing maternal bonding, and reducing the risk of severe complications like infections and hypothermia, KMC offers a cost-effective and impactful approach to improving survival outcomes in this vulnerable population.
Incidence of Complications
Time frame: Up to 24 weeks
Incidence of Complications Including infections, intraventricular hemorrhage, and necrotizing enterocolitis.
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 25 Feb 2025.
- Derived from this study: PubMed 40241073Ramadan OME, Alshammari AM, Alruwaili AN, Elsharkawy NB, Alhaiti A, Baraka NIM. Transforming neonatal nursing: a randomized controlled trial comparing kangaroo care and standard protocols for survival in preterm infants with respiratory distress syndrome. BMC Nurs. 2025 Apr 16;24(1):430. doi: 10.1186/s12912-025-03088-8.
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Effect of Kangaroo Mother Care on Energy Utilization in Preterm Neonates
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EFFECT OF KANGAROO MOTHER CARE ON HOSPITAL OUTCOME IN LOW BIRTH WEIGHT
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Kangaroo Mother Care in people with Kangaroo-Mother Care and Preterm Infants, run by Jouf University at 1 site in Egypt.
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 25 Feb 2025. 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 Egypt. 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?
Survival Rates (time frame: Up to 24 weeks). The study lists 2 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 NCT06707376, which also lists 1 linked publication.
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 25 Feb 2025.