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

NCT05491265 | Unknown DMC

• 1 other identifier: F.1-1/2015/ERB/SZABMU/955
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Kangaroo Mother Care Method

Keywords

vital signs; Intensive care

Outcome Measures

Primary Outcomes (3)

• Temperature

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

  2 hours

• Heart rate

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

  2 hours

• Oxygen Saturation

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

  2 hours

Study Arms (2)

Kangaroo mother care

EXPERIMENTAL

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

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

Interventions

Intermittent Kangaroo mother care 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 .

Kangaroo mother care

Eligibility Criteria

• Age: 28 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shaheed Zulfiqar Ali Bhutto Medical University: lead
• UNICEF: collaborator

Study Sites (1)

Pakistan institute of medical sciences

Islamabad, 46000, Pakistan

RECRUITING

Study Officials

• Dr Maimoona Saeed, MBBS

  Shaheed Zulfiqar Ali Bhutto Medical University

  PRINCIPAL INVESTIGATOR

• Dr Fibhaa Syed, MBBS,FCPS

  Shaheed Zulfiqar Ali Bhutto Medical University

  STUDY CHAIR

Central Study Contacts

Dr Maimoona Saeed, MBBS

CONTACT

00923165415720; dr.maimoona@live.com

Dr Syeda Shireen Gul, MBBS,FCPS

CONTACT

00923002263969; syedashireengul@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Resident

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

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 8, 2022
• Study Start: April 4, 2022
• Primary Completion: December 3, 2022
• Study Completion: December 3, 2022
• Last Updated: August 8, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)