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

Weight Gain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05640297
• Other study ID #: 3838
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Weight Gain

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