Clinical trial NCT04619758: Emollient Therapy In Preterm & Low Birth Weight Neonates: A Randomized Clinical Trial
Official title: Emollient Therapy In Preterm & Low Birth Weight Neonates: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Gain
Keywords: Emollient Low birth weight Preterm Weight Length.
Lead sponsor: King Edward Medical University
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 140
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to assess the impact of emollient therapy on gain in weight and length among preterm and low birth weight babies.

Detailed description: The study will be conducted at the Department of Pediatric Medicine unit 1, KEMU / Mayo Hospital Lahore. Total of 140 neonates fulfilling the eligibility criteria will be enrolled. They will be randomly divided into two groups - A and B. Mothers of the neonates in group A will be advised massage with sunflower oil while mothers of the neonates in group B will be advised massage without any emollient. Babies will closely be followed up and their weight and length will be measured at six months of age and will be analyzed using SPSS v 23.0.

Eligibility criteria: Inclusion Criteria:

* Neonates of both genders
* Both breast fed and non-breast fed infants
* Neonates with birth weight between 1.5 and 2.5 kg
* Preterm neonates born between 28 and 37 completed weeks of gestation

Exclusion Criteria:

* Neonates with genetic syndrome, infection or with a history of admission in NICU due to any reason will be excluded.

Primary outcomes:
measure: Change in Weight
timeFrame: Six Months
measure: Change in Length
timeFrame: Six Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: King Edward Medical University
state: Punjab
Study officials:
affiliation: King Edward Medical University, Lahore, Pakistan.
name: Abdul Ahad Jamshaid, FCPS MRCPCH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salam RA, Darmstadt GL, Bhutta ZA. Effect of emollient therapy on clinical outcomes in preterm neonates in Pakistan: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2015 May;100(3):F210-5. doi: 10.1136/archdischild-2014-307157. Epub 2015 Jan 30.
citation: Jabraeile M, Rasooly AS, Farshi MR, Malakouti J. Effect of olive oil massage on weight gain in preterm infants: A randomized controlled clinical trial. Niger Med J. 2016 May-Jun;57(3):160-3. doi: 10.4103/0300-1652.184060.
citation: Akhavan Karbasi S, Golestan M, Fallah R, Golshan M, Dehghan Z. Effect of body massage on increase of low birth weight neonates growth parameters: A randomized clinical trial. Iran J Reprod Med. 2013 Jul;11(7):583-8.
citation: Kumar J, Upadhyay A, Dwivedi AK, Gothwal S, Jaiswal V, Aggarwal S. Effect of oil massage on growth in preterm neonates less than 1800 g: a randomized control trial. Indian J Pediatr. 2013 Jun;80(6):465-9. doi: 10.1007/s12098-012-0869-7. Epub 2012 Oct 4.
citation: Salam RA, Das JK, Darmstadt GL, Bhutta ZA. Emollient therapy for preterm newborn infants--evidence from the developing world. BMC Public Health. 2013;13 Suppl 3(Suppl 3):S31. doi: 10.1186/1471-2458-13-S3-S31. Epub 2013 Dec 20.