Kangaroo Mother Care MethodNCT05491265
Impact of Intermittent Kangaroo Mother Care Versus Conventional Care Method on Vital Sign and Arterial Oxygen Saturation in Preterm Hospitalized in Neonatal Intensive Care Unit
A study testing Intermittent Kangaroo mother care in people with Kangaroo Mother Care Method, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
Trial summary
To study the vital sign ,oxygen arterial saturation of preterm babies provided skin to skin contact versus conventional care from birth to discharge Read more about this study
- Who is it for?
- Ages 28 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Kangaroo Mother Care Method
- What is being tested?
- Intermittent Kangaroo mother care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Apr 2022to 3 Dec 2022
- 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 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Birth weight between 1200 to 1800 gram Gestational age 28 weeks to 36+6 weeks Clinically stable Off oxygen support Hemodynamically stable baby No surgery performed on baby No cardiac ,nervous system problems
- -
Who cannot join
- Extreme preterm<28 weeks Hemodynamically unstable Underlying cardiac problems Surgical problems Those who do not give consent Unwell or hospitalized mother who is bed bound problems Gestational age 37 weeks or >37 weeks
- -
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Pakistan institute of medical sciences
Islamabad, 46000
Dr Maimoona Saeed, MBBS
About this study
Official title: Impact of Intermittent Kangaroo Mother Care Versus Conventional Care Method on Vital Signs and Arterial Oxygen Saturation in Preterm Hospitalized in Neonatal Intensive Care Unit : A Randomized Controlled Trail
- To study the vital sign ,oxygen arterial saturation of preterm babies provided skin to skin contact versus conventional care from birth to discharge
Read the detailed description
The mother and baby will be supported by a nurse and researcher. Hence, the study group mothers will be trained properly, and the required information and explanations along with displaying the video description about the KMC method will be provided for them, and the KMC will apply to their newborns.
Thus, the naked newborn, only wearing diaper and cap, was placed in a straight state between the mother's breasts and supported by a cloth bag. The caring is performed for 3 consecutive days, three times a day and each time for 2-h.
The procedure will be conducted for all samples by the head nurse and with the researcher's presence and monitoring in the morning shift, and the mothers should be supported and encouraged during the caring process. The changes in pulse ,respiration, temperature, and arterial oxygen saturation rate of the study group is controlled and recorded during the care process, at 60 min after starting the procedure and at the end of caring process before returning the newborn to the incubator. The mentioned items in the control group (conventional incubator care) should also measure and recorded simultaneously with the study group. The pulse oximetry in NICU used to measure the arterial oxygen saturation rate, and a mercury thermometer was used to measure the temperature with an auxiliary approach for 3 min. To maintain the reliability of the instrument during the research, the same pulse oximetry device and monitoring system will be applied to newborns in the same situation. The pulse oximetry probe will be taped to the toe of the left foot of all newborns
- Conditions
- Kangaroo Mother Care Method
- Being tested
- Intermittent Kangaroo mother care
- Keywords
- vital signs, Intensive care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Kangaroo mother careBehavioural
Skin to skin contact between mother and preterm newborn between gestational age 28 weeks to 36+6 weeks for three sessions per day ,each contact session of two hours .
| Study group | Role | What they receive |
|---|---|---|
| Kangaroo mother care | Experimental | To see the impact of intermittent kangaroo mother care on temperature ,oxygen saturation and heart rate. Receives: Behavioral: Intermittent Kangaroo mother care |
| standard of care | No intervention | To observe temperature ,oxygen saturation and heart rate in preterm neonates not given kangaroo care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature
To measure temperature difference in babies provided with kangaroo mother care vs incubator care
Measured: 2 hours
Heart rate
To measure heart rate variations in babies provided with kangaroo mother care vs incubator care
Measured: 2 hours
Oxygen Saturation
To measure oxygen saturation in babies provided with kangaroo mother care vs
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start4 Apr 2022
- Primary completion3 Dec 2022 (estimated)
- Study completion3 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- \- To study the vital sign ,oxygen arterial saturation of preterm babies provided skin to skin contact versus conventional care from birth to discharge
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- UNICEF
- Responsible party
- Principal investigator, Maimoona Saeed, Shaheed Zulfiqar Ali Bhutto Medical University
- Investigators
- Dr Maimoona Saeed, MBBS, Principal investigator, Shaheed Zulfiqar Ali Bhutto Medical UniversityDr Fibhaa Syed, MBBS,FCPS, Study chair, Shaheed Zulfiqar Ali Bhutto Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491265
- Sponsor's protocol ID
- F.1-1/2015/ERB/SZABMU/955
- Status last verified
- Aug 2022
- First submitted
- 4 Aug 2022
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intermittent Kangaroo Mother Care Versus Conventional Care Method on Vital Signs and Arterial Oxygen Saturation in Preterm Hospitalized in Neonatal Intensive Care Unit : A Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT05491265
- Acronym / sponsor ID
- F.1-1/2015/ERB/SZABMU/955
- Conditions
- Kangaroo Mother Care Method
- Keywords
- vital signs, Intensive care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical UniversityUniversity, hospital or other
- Collaborators
- UNICEF
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 3 Dec 2022 (estimated)
- Study completion
- 3 Dec 2022 (estimated)
- First posted
- 8 Aug 2022 (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.
- To study the vital sign ,oxygen arterial saturation of preterm babies provided skin to skin contact versus conventional care from birth to discharge
Detailed description
The mother and baby will be supported by a nurse and researcher. Hence, the study group mothers will be trained properly, and the required information and explanations along with displaying the video description about the KMC method will be provided for them, and the KMC will apply to their newborns.
Thus, the naked newborn, only wearing diaper and cap, was placed in a straight state between the mother's breasts and supported by a cloth bag. The caring is performed for 3 consecutive days, three times a day and each time for 2-h.
The procedure will be conducted for all samples by the head nurse and with the researcher's presence and monitoring in the morning shift, and the mothers should be supported and encouraged during the caring process. The changes in pulse ,respiration, temperature, and arterial oxygen saturation rate of the study group is controlled and recorded during the care process, at 60 min after starting the procedure and at the end of caring process before returning the newborn to the incubator. The mentioned items in the control group (conventional incubator care) should also measure and recorded simultaneously with the study group. The pulse oximetry in NICU used to measure the arterial oxygen saturation rate, and a mercury thermometer was used to measure the temperature with an auxiliary approach for 3 min. To maintain the reliability of the instrument during the research, the same pulse oximetry device and monitoring system will be applied to newborns in the same situation. The pulse oximetry probe will be taped to the toe of the left foot of all newborns
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- - To study the vital sign ,oxygen arterial saturation of preterm babies provided skin to skin contact versus conventional care from birth to discharge
| Arm | Type | Receives |
|---|---|---|
| Kangaroo mother care | Experimental | Behavioral: Intermittent Kangaroo mother careTo see the impact of intermittent kangaroo mother care on temperature ,oxygen saturation and heart rate. |
| standard of care | No intervention | –To observe temperature ,oxygen saturation and heart rate in preterm neonates not given kangaroo care |
Who may qualify
- Ages
- 28 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Birth weight between 1200 to 1800 gram Gestational age 28 weeks to 36+6 weeks Clinically stable Off oxygen support Hemodynamically stable baby No surgery performed on baby No cardiac ,nervous system problems
- -
Key exclusion criteria (2 listed)
- Extreme preterm<28 weeks Hemodynamically unstable Underlying cardiac problems Surgical problems Those who do not give consent Unwell or hospitalized mother who is bed bound problems Gestational age 37 weeks or >37 weeks
- -
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 |
|---|---|---|
| Intermittent Kangaroo mother careSkin to skin contact between mother and preterm newborn between gestational age 28 weeks to 36+6 weeks for three sessions per day ,each contact session of two hours . | Behavioural | Kangaroo mother care |
Primary outcome
Temperature
Time frame: 2 hours
To measure temperature difference in babies provided with kangaroo mother care vs incubator care
Heart rate
Time frame: 2 hours
To measure heart rate variations in babies provided with kangaroo mother care vs incubator care
Oxygen Saturation
Time frame: 2 hours
To measure oxygen saturation in babies provided with kangaroo mother care vs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Kangaroo Mother Care Method
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Low Birth Weight, Kangaroo Mother Care
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Effect of Kangaroo Mother Care on Energy Utilization in Preterm Neonates
Impact of Kangroo on Neonates
Not yet recruiting
EFFECT OF KANGAROO MOTHER CARE ON HOSPITAL OUTCOME IN LOW BIRTH WEIGHT
Low Birth Weight Among Neonates
Not yet recruiting
Effectiveness of Simulation-based Training Delivered to Special Newborn Care Providers on Resuscitation Management and Kangaroo Mother Care: Simulation-based Training for Asyphxia in Babies Trial (STAR-Baby Trial)
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Recruiting
Skin Conductance in Ventilated Preterms
Mechanical Ventilation, Pain
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.
Dr Maimoona Saeed, MBBS principal investigator
Shaheed Zulfiqar Ali Bhutto Medical University
Dr Fibhaa Syed, MBBS,FCPS study chair
Shaheed Zulfiqar Ali Bhutto Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Kangaroo mother care in people with Kangaroo Mother Care Method, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Aug 2022. 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Maimoona Saeed, MBBS (00923165415720, dr.maimoona@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temperature (time frame: 2 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Aug 2022.