NCT04619758

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 6, 2020

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

6 months

First QC Date

October 26, 2020

Last Update Submit

November 2, 2020

Conditions

Weight Gain

Keywords

Emollient Low birth weight Preterm Weight Length.

Outcome Measures

Primary Outcomes (2)

  • Change in Weight

    Neonates will be called for follow up after 6 months of application of sunflower oil and their weights will be measured in kilograms using digital weighing scale.

    Six Months

  • Change in Length

    Neonates will be called for follow up after 6 months of application of sunflower oil and their lengths will be measured in centimeters using infant length scale.

    Six Months

Study Arms (2)

Emollient Group

EXPERIMENTAL

Mothers of the neonates in group A will be advised massage with sunflower oil.

Other: Emollient (sunflower oil)

Non-Emollient Group

NO INTERVENTION

Mothers of the neonates in group B will be advised massage without any emollient.

Interventions

Emollient (sunflower oil)OTHER

In group A, mothers will be advised to massage their babies with sunflower oil at a dose of 10 mL/kg/day twice a day in equally divided amounts. They will be called for follow up after six months of application of sunflower oil.

Emollient Group

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Edward Medical University

Lahore, Punjab Province, 38000, Pakistan

Location

Related Publications (5)

  • 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.

    PMID: 25637007BACKGROUND

  • 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.

    PMID: 27397955BACKGROUND

  • 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.

    PMID: 24639794BACKGROUND

  • 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.

    PMID: 23054851BACKGROUND

  • 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.

    PMID: 24564550BACKGROUND

MeSH Terms

Conditions

Weight Gain

Interventions

EmollientsSunflower Oil

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dermatologic AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesPlant OilsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Abdul Ahad Jamshaid, FCPS MRCPCH

    King Edward Medical University, Lahore, Pakistan.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Registrar

Study Record Dates

First Submitted

October 26, 2020

First Posted

November 6, 2020

Study Start

January 1, 2018

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

November 6, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)