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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05640297
Other study ID # 3838
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date March 30, 2022
Est. completion date October 1, 2023

Study information

Verified date March 2023
Source Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 33
Est. completion date October 1, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Hour to 28 Months
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
KMC with Massage therapy
investigator will provide tactile and kinesthetic massage

Locations

Country Name City State
Bangladesh BSMMU Dhaka

Sponsors (2)

Lead Sponsor Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh Bangladesh College Of Physicians And Surgeons (BCPS)

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type Measure Description Time frame Safety issue
Other length of hospital stay in days to see how many days the baby needs hospital care 18 months
Primary Weight in grams Pattern of weight gain in grams using KINLEE EBST-20 weighing scale. 18 months
Secondary OFC in centimeter pattern of head growth using measuring tape 18 months
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