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

Primary Purpose

Weight Gain

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
KMC with Massage therapy
Sponsored by
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Weight Gain

Eligibility Criteria

1 Hour - 28 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 1. 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. 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.

Sites / Locations

  • BSMMU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

KMC with Massage therapy

KMC only

Arm Description

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

Preterm low birth weight babies who will get KMC only

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

OFC in centimeter
pattern of head growth using measuring tape

Full Information

First Posted
November 15, 2022
Last Updated
March 28, 2023
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Collaborators
Bangladesh College Of Physicians And Surgeons (BCPS)
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1. Study Identification

Unique Protocol Identification Number
NCT05640297
Brief Title
"Impact of Kangaroo Mother Care Plus Massage Therapy on Growth of Preterm Low Birth Weight Infants at Discharge"
Official Title
"Impact of Kangaroo Mother Care Plus Massage Therapy on Growth of Preterm Low Birth Weight Infants at Discharge"
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 30, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Collaborators
Bangladesh College Of Physicians And Surgeons (BCPS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Gain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
KMC with Massage therapy
Arm Type
Experimental
Arm Description
Preterm low birth weight babies who will get KMC will also receive massage therapy
Arm Title
KMC only
Arm Type
No Intervention
Arm Description
Preterm low birth weight babies who will get KMC only
Intervention Type
Behavioral
Intervention Name(s)
KMC with Massage therapy
Intervention Description
investigator will provide tactile and kinesthetic massage
Primary Outcome Measure Information:
Title
Weight in grams
Description
Pattern of weight gain in grams using KINLEE EBST-20 weighing scale.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
OFC in centimeter
Description
pattern of head growth using measuring tape
Time Frame
18 months
Other Pre-specified Outcome Measures:
Title
length of hospital stay in days
Description
to see how many days the baby needs hospital care
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
28 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sonia aktar, MBBS,DCH
Organizational Affiliation
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
BSMMU
City
Dhaka
ZIP/Postal Code
1000
Country
Bangladesh

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After completion principle investigator will share
IPD Sharing Time Frame
december,2022

Learn more about this trial

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

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