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

NCT ID: NCT05491265

Last Updated: 2022-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-04

Study Completion Date

2022-12-03

Brief Summary

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\- 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

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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

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Kangaroo Mother Care Method

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

\- To study the vital sign ,oxygen arterial saturation of preterm babies provided skin to skin contact versus conventional care from birth to discharge
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Kangaroo mother care

To see the impact of intermittent kangaroo mother care on temperature ,oxygen saturation and heart rate.

Group Type EXPERIMENTAL

Intermittent Kangaroo mother care

Intervention Type BEHAVIORAL

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 .

standard of care

To observe temperature ,oxygen saturation and heart rate in preterm neonates not given kangaroo care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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 .

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

\-

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

\-
Minimum Eligible Age

28 Weeks

Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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UNICEF

OTHER

Sponsor Role collaborator

Shaheed Zulfiqar Ali Bhutto Medical University

OTHER

Sponsor Role lead

Responsible Party

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Maimoona Saeed

MD Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr Maimoona Saeed, MBBS

Role: PRINCIPAL_INVESTIGATOR

Shaheed Zulfiqar Ali Bhutto Medical University

Dr Fibhaa Syed, MBBS,FCPS

Role: STUDY_CHAIR

Shaheed Zulfiqar Ali Bhutto Medical University

Locations

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Pakistan institute of medical sciences

Islamabad, , Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Dr Maimoona Saeed, MBBS

Role: CONTACT

00923165415720

Dr Syeda Shireen Gul, MBBS,FCPS

Role: CONTACT

00923002263969

Other Identifiers

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F.1-1/2015/ERB/SZABMU/955

Identifier Type: -

Identifier Source: org_study_id

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