Clinical trial NCT05640297: "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
Overall status: UNKNOWN
Phase: NA
Conditions: Weight Gain
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor class: OTHER
Collaborators: name: Bangladesh College Of Physicians And Surgeons (BCPS)
First posted: 2022-12-07
Enrollment: 33
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: OTHER

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.

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.

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.

Primary outcomes:
measure: Weight in grams
timeFrame: 18 months
Secondary outcomes:
measure: OFC in centimeter
timeFrame: 18 months
Other outcomes:
measure: length of hospital stay in days
timeFrame: 18 months
Locations:
city: Dhaka
country: Bangladesh
facility: BSMMU
Study officials:
affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
name: sonia aktar, MBBS,DCH
role: PRINCIPAL_INVESTIGATOR
References: