"Impact of Kangaroo Mother Care Plus Massage Therapy on Growth of Preterm Low Birth Weight Infants at Discharge"

NCT05640297 | Unknown DMC

• 1 other identifier: 3838
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Kangaroo mother care plus massage therapy will lead to improved growth of preterm low birth weight infants at discharge.

Conditions

Weight Gain

Outcome Measures

Primary Outcomes (1)

• Weight in grams

  Pattern of weight gain in grams using KINLEE EBST-20 weighing scale.

  18 months

Secondary Outcomes (1)

• OFC in centimeter

  18 months

Other Outcomes (1)

• length of hospital stay in days

  18 months

Study Arms (2)

KMC with Massage therapy

EXPERIMENTAL

Preterm low birth weight babies who will get KMC will also receive massage therapy

Behavioral: KMC with Massage therapy

KMC only

NO INTERVENTION

Preterm low birth weight babies who will get KMC only

Interventions

KMC with Massage therapy BEHAVIORAL

investigator will provide tactile and kinesthetic massage

KMC with Massage therapy

Eligibility Criteria

• Age: 1 Hour - 28 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \. Gestational age \<34 weeks. or 2. Neonates weighing less than 2000 gm. With any one of the following
• Hemodynamically stable.
• Preterm neonate with up to 2 L/min O2 support by nasal canula or prong.

You may not qualify if:

• Gestational age \<34 weeks. or
• Neonates weighing less than 2000 gm. With any one of the following
• Hemodynamically stable.
• Preterm neonate with up to 2 L/min O2 support by nasal canula or prong.
• Hemodynamically unstable critically ill neonates.
• Newborn with severe perinatal asphyxia and seizure
• Newborn requiring exchange transfusion.
• Newborn with major congenital and chromosomal abnormalities.
• Newborn with sepsis, IVH, shock, necrotizing enterocolitis.
• Newborn with major surgical illness.

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead
• Bangladesh College Of Physicians And Surgeons (BCPS): collaborator

Study Sites (1)

BSMMU

Dhaka, 1000, Bangladesh

Location

MeSH Terms

Conditions

Weight Gain

Interventions

Massage

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• sonia aktar, MBBS,DCH

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 7, 2022
• Study Start: March 30, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: december,2022

Locations

BA (1)