Skip to main content
Clinical Trials/NCT05640297
NCT05640297UnknownNot Applicable

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

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh1 site in 1 country33 target enrollmentStarted: March 30, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
33
Locations
1
Primary Endpoint
Weight in grams

Study Overview

Brief Summary

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

Detailed Description

Primary phase of the transition from the fetal to post-natal period is the most important, vulnerable and stressful phase in human life. Hence, care methods that facilitate better adaptation of neonates with early post¬natal environment have an important role in growth of newborns. Attachment is a unique relationship between the parents and their infants that begins during pregnancy when fetus grows in uterus and continues to the postnatal period with the relationship of mother and baby. This reciprocal parent-infant relationship is an essential element of the attachment process that helps relaxation of both mother and the infant. Kangaroo mother care has facilitated infant growth and decreased morbidities and hospital stay. Adding massage therapy may potentiate the kangaroo mother care benefits and better growth in preterm low birth weight infants admitted in neonatal intensive care unit. However, there is a very few published studies from Bangladesh regarding this. The objective of this study is to evaluate whether kangaroo mother care plus massage therapy is associated with better growth of preterm low birth weight infants.

This study will be conducted in the department of Neonatology in Bangabandhu Sheikh Mujib Medical University over a period of eighteen months. After detailed history taking and thorough general and systemic examination the newborn will enter in to intervention or control group after taking informed written consent. Randomization will be done by random allocation software (version 2.0 developed by Mahmood Saghaei, Iran). Patient will be enrolled according to the inclusion and exclusion criteria. Thereafter control group will receive standard kangaroo mother care and intervention group will get massage therapy along with kangaroo mother care, up to discharge both group will be meticulously monitored by the investigator. Data will be collected by structured questionnaire and analysis will be done by The Statistical Package for Social Sciences (SPSS), version 25.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
1 Hour to 28 Months (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •1. 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.

Exclusion Criteria

  • •Inclusion Criteria:
  • •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.
  • •Exclusion Criteria:
  • •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.

Arms & Interventions

KMC with Massage therapy

Experimental

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

Intervention: KMC with Massage therapy (Behavioral)

KMC only

No Intervention

Preterm low birth weight babies who will get KMC only

Outcomes

Primary Outcomes

Weight in grams

Time Frame: 18 months

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

Secondary Outcomes

  • OFC in centimeter(18 months)

Investigators

Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr. Sonia Aktar

Doctor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study Sites (1)

Loading locations...

Similar Trials