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

Kangaroo Mother Care Method Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05491265
• Other study ID #: F.1-1/2015/ERB/SZABMU/955
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2022
• Est. completion date: December 3, 2022

Study information

• Verified date: August 2022
• Source: Shaheed Zulfiqar Ali Bhutto Medical University
• Contact: Dr Maimoona Saeed, MBBS
• Phone: 00923165415720
• Email: dr.maimoona[@]live.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 3, 2022
• Est. primary completion date: December 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 28 Weeks to 37 Weeks

Eligibility

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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Related Conditions & MeSH terms

• Kangaroo Mother Care Method

Intervention

Behavioral:
• Intermittent Kangaroo mother care
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 .

Locations

Country	Name	City	State
Pakistan	Pakistan institute of medical sciences	Islamabad

Sponsors (2)

Lead Sponsor	Collaborator
Shaheed Zulfiqar Ali Bhutto Medical University	UNICEF

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Temperature	To measure temperature difference in babies provided with kangaroo mother care vs incubator care	2 hours
Primary	Heart rate	To measure heart rate variations in babies provided with kangaroo mother care vs incubator care	2 hours
Primary	Oxygen Saturation	To measure oxygen saturation in babies provided with kangaroo mother care vs	2 hours