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

NCT ID: NCT05640297

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-30
• Study Completion Date: 2023-10-01

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.

Conditions

Weight Gain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

KMC with Massage therapy

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

Group Type: EXPERIMENTAL

KMC with Massage therapy

Intervention Type: BEHAVIORAL

investigator will provide tactile and kinesthetic massage

KMC only

Preterm low birth weight babies who will get KMC only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

KMC with Massage therapy

investigator will provide tactile and kinesthetic massage

Intervention Type: BEHAVIORAL

Eligibility 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.

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.

• Minimum Eligible Age: 1 Hour
• Maximum Eligible Age: 28 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bangladesh College Of Physicians And Surgeons (BCPS)

OTHER

Sponsor Role: collaborator

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role: lead

Responsible Party

Dr. Sonia Aktar

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

sonia aktar, MBBS,DCH

Role: PRINCIPAL_INVESTIGATOR

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Locations

BSMMU

Dhaka, , Bangladesh

Countries

Bangladesh

Other Identifiers

3838

Identifier Type: -

Identifier Source: org_study_id