CClinicalTrials.gg
Status unknownNCT05491265Updated Aug 8, 2022

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

An interventional study of Intermittent Kangaroo mother care in Kangaroo Mother Care Method, sponsored by Shaheed Zulfiqar Ali Bhutto Medical University. Status unknown at 1 site in Pakistan. Open to participants aged 28 Weeks to 37 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-08.

Sponsored by Shaheed Zulfiqar Ali Bhutto Medical University · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Apr 2022, registered Aug 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
28 Weeks to 37 Weeks
Sex
All
01

Study 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 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

02

Conditions studied

  • Kangaroo Mother Care Method

Keywords

  • vital signs
  • Intensive care
03

In context

Lead sponsor

Shaheed Zulfiqar Ali Bhutto Medical University is the lead sponsor of 32 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
28 Weeks to 37 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes

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

-

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

-

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Kangaroo mother care

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

    Behavioral: Intermittent Kangaroo mother care

  • No intervention
    standard of care

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

Interventions

  • BehavioralIntermittent 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 .

06

What researchers measure

Primary outcomes

  1. Temperature

    To measure temperature difference in babies provided with kangaroo mother care vs incubator care

    Time frame: 2 hours

  2. Heart rate

    To measure heart rate variations in babies provided with kangaroo mother care vs incubator care

    Time frame: 2 hours

  3. Oxygen Saturation

    To measure oxygen saturation in babies provided with kangaroo mother care vs

    Time frame: 2 hours

07

Study locations

1 of 1 sites recruiting
  • Pakistan institute of medical sciences
    Islamabad, 46000, Pakistan
    • Dr Maimoona Saeed, MBBS · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05491265
Lead sponsor
Shaheed Zulfiqar Ali Bhutto Medical University
Collaborators
UNICEF
Responsible party
Maimoona Saeed (MD Resident, Shaheed Zulfiqar Ali Bhutto Medical University) — Principal investigator
First posted
Aug 8, 2022
Start date
Apr 4, 2022
Primary completion
Dec 3, 2022 (estimated)
Completion
Dec 3, 2022 (estimated)
Last update
Aug 8, 2022

Study contacts

Dr Maimoona Saeed, MBBS
Contact
dr.maimoona@live.com
00923165415720
Dr Syeda Shireen Gul, MBBS,FCPS
Contact
syedashireengul@gmail.com
00923002263969
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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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