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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Weight Gain
• Intervention / Treatment: Behavioral: KMC with Massage therapy

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 Type: Interventional
• Enrollment (Anticipated): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bangladesh
  • Dhaka, Bangladesh, 1000
    • BSMMU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 2 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1. Gestational age <34 weeks. or 2. Neonates weighing less than 2000 gm. With any one of the following

  1. Hemodynamically stable.
  2. Preterm neonate with up to 2 L/min O2 support by nasal canula or prong.

Exclusion Criteria:

• Inclusion Criteria:

  1. Gestational age <34 weeks. or

  2. Neonates weighing less than 2000 gm. With any one of the following

     1. Hemodynamically stable.
     2. Preterm neonate with up to 2 L/min O2 support by nasal canula or prong.

Exclusion Criteria:

1. Hemodynamically unstable critically ill neonates.
2. Newborn with severe perinatal asphyxia and seizure
3. Newborn requiring exchange transfusion.
4. Newborn with major congenital and chromosomal abnormalities.
5. Newborn with sepsis, IVH, shock, necrotizing enterocolitis.
6. Newborn with major surgical illness.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KMC with Massage therapy; Preterm low birth weight babies who will get KMC will also receive massage therapy	Behavioral: KMC with Massage therapy; investigator will provide tactile and kinesthetic massage
No Intervention: KMC only; Preterm low birth weight babies who will get KMC only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight in grams	Pattern of weight gain in grams using KINLEE EBST-20 weighing scale.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OFC in centimeter	pattern of head growth using measuring tape	18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of hospital stay in days	to see how many days the baby needs hospital care	18 months

Collaborators and Investigators

• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Collaborators: Bangladesh College Of Physicians And Surgeons (BCPS)
• Investigators: Principal Investigator: sonia aktar, MBBS,DCH, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: December 3, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Body Weight; Birth Weight; Weight Gain
• Other Study ID Numbers: 3838

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After completion principle investigator will share
• IPD Sharing Time Frame: december,2022
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No