Clinical trial NCT05491265: 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kangaroo Mother Care Method
Keywords: vital signs
Intensive care
Lead sponsor: Shaheed Zulfiqar Ali Bhutto Medical University
Sponsor class: OTHER
Collaborators: name: UNICEF
First posted: 2022-08-08
Enrollment: 120
Sex: ALL
Minimum age (years): 28
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: SUPPORTIVE_CARE

Brief summary: - 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

Eligibility criteria: Inclusion Criteria:

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

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Exclusion Criteria:

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

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Primary outcomes:
measure: Temperature
timeFrame: 2 hours
measure: Heart rate
timeFrame: 2 hours
measure: Oxygen Saturation
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Pakistan institute of medical sciences
Study officials:
affiliation: Shaheed Zulfiqar Ali Bhutto Medical University
name: Dr Maimoona Saeed, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Shaheed Zulfiqar Ali Bhutto Medical University
name: Dr Fibhaa Syed, MBBS,FCPS
role: STUDY_CHAIR
References: