Umbilical Cord Care in Term Neonates: The Role of Wondaleaf Adhesive Pouch (WLAP)
Primary Purpose
Umbilical Cord Infection, Umbilical Sepsis, Neonatal Sepsis
Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Adhesive pouch
Sponsored by
About this trial
This is an interventional supportive care trial for Umbilical Cord Infection focused on measuring Umbilical cord care, Omphalitis, Neonatal sepsis, Barrier dressing
Eligibility Criteria
Inclusion Criteria:
- Normal term neonates
- Born in the study site (hospital)
Exclusion Criteria:
- Congenital abnormalities
- Apgar score less than 7
- Neonatal conditions
Sites / Locations
- AIMST University Malaysia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Adhesive pouch
Conventional care
Arm Description
Experimental group will be applied with Wondaleaf adhesive pouch to cover up the umbilical stump
Control group will not be applied with Wondaleaf adhesive pouch, but the umbilical stump is managed with conventional care, by cleaning with antiseptic.
Outcomes
Primary Outcome Measures
Umbilical cord infection rate
Number of neonates with umbilical cord infection. Comparing the umbilical cord infection rate between experimental group and control group. If the experimental group with WLAP applied has a lower rate of infection against the published literature, then WLAP can be shown to be effective.
Secondary Outcome Measures
Duration of cord detachment
Number of days for umbilical cord detachment. If the duration of cord detachment for experimental group is equal to control group, then Wondaleaf Adhesive Pouch (WLAP) has no effect on the detachment mechanism of the umbilical stump
Full Information
NCT ID
NCT05569551
First Posted
September 25, 2022
Last Updated
August 26, 2023
Sponsor
AIMST University Malaysia
Collaborators
Putra Medical Centre, Malaysia, Twin Catalyst Sdn Bhd, Malaysia
1. Study Identification
Unique Protocol Identification Number
NCT05569551
Brief Title
Umbilical Cord Care in Term Neonates: The Role of Wondaleaf Adhesive Pouch (WLAP)
Official Title
Umbilical Cord Care in Term Neonates: The Revolutionized Role of Wondaleaf Adhesive Pouch (WLAP) in the Prevention of Neonatal Sepsis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 14, 2022 (Actual)
Primary Completion Date
June 15, 2023 (Actual)
Study Completion Date
June 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
AIMST University Malaysia
Collaborators
Putra Medical Centre, Malaysia, Twin Catalyst Sdn Bhd, Malaysia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of Wondaleaf Adhesive Pouch (WLAP) in the prevention of umbilical cord infection among full-term neonates.
Methods: This is a prospective double-blinded randomized controlled trial on 218 term neonates in which 109 each was randomly assigned to interventional and conventional group. The Wondaleaf Adhesive Pouch (WLAP) dressings were applied to umbilical stumps of the term neonates in interventional group by trained midwife on the first day immediate after delivery. Mothers or caregivers were taught to observe the umbilical stump the subsequent days till the stump detached. The observations are supported by photographic images taken by caregiver and evaluated by the trial team and reporting inflammation with immediately removal of WLAP or otherwise no sign of infection till the detachment of stump.
Detailed Description
Background: Neonatal death was the serious global burden with three-quarter of it was attributable to neonatal sepsis. It was estimated that the annual incidence cases have reached 1.3 million and posed significant economic impact to many low-income and middle-income countries. The purpose of this study is to evaluate the efficacy of Wondaleaf Adhesive Pouch (WLAP) in the prevention of umbilical cord infection among full-term neonates.
Methods: This is a prospective double-blinded randomized controlled trial conducted in one hospital located in state of Kedah, Malaysia on 218 term neonates in which 109 each was randomly assigned to interventional and conventional group. The Wondaleaf Adhesive Pouch (WLAP) dressings were applied to umbilical stumps of the term neonates in interventional group by trained midwife on the first day immediate after delivery. Mothers or caregivers will be taught to observe the umbilical stump the subsequent days till the stump detached. The observations are supported by photographic images taken by caregiver to be evaluated by the trial team and reporting inflammation with immediately removal of WLAP or otherwise no sign of infection till the detachment of stump.
Results and conclusion will be reported after completion of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Umbilical Cord Infection, Umbilical Sepsis, Neonatal Sepsis
Keywords
Umbilical cord care, Omphalitis, Neonatal sepsis, Barrier dressing
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Masking on participants and investigator
Allocation
Randomized
Enrollment
218 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adhesive pouch
Arm Type
Experimental
Arm Description
Experimental group will be applied with Wondaleaf adhesive pouch to cover up the umbilical stump
Arm Title
Conventional care
Arm Type
No Intervention
Arm Description
Control group will not be applied with Wondaleaf adhesive pouch, but the umbilical stump is managed with conventional care, by cleaning with antiseptic.
Intervention Type
Device
Intervention Name(s)
Adhesive pouch
Other Intervention Name(s)
Wondaleaf adhesive pouch (WLAP)
Intervention Description
Is a barrier dressing categorized under class C medical device. It is used to seal up the umbilical stump to prevent contamination until its cord detachment. It has an adhesive film that sticks to skin with a centrally located non-adhesive pouch ensuring that zero pressure is applied on the umbilicus. It is made of polyurethane, the same material as transparent intravenous cannula dressings making it hypoallergenic waterproof and breathable.
Primary Outcome Measure Information:
Title
Umbilical cord infection rate
Description
Number of neonates with umbilical cord infection. Comparing the umbilical cord infection rate between experimental group and control group. If the experimental group with WLAP applied has a lower rate of infection against the published literature, then WLAP can be shown to be effective.
Time Frame
From the date of randomization until the date of cord infection occurred, assessed up to 3 weeks
Secondary Outcome Measure Information:
Title
Duration of cord detachment
Description
Number of days for umbilical cord detachment. If the duration of cord detachment for experimental group is equal to control group, then Wondaleaf Adhesive Pouch (WLAP) has no effect on the detachment mechanism of the umbilical stump
Time Frame
From date of randomization until the date of cord detached, assessed up to 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
2 Hours
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Normal term neonates
Born in the study site (hospital)
Exclusion Criteria:
Congenital abnormalities
Apgar score less than 7
Neonatal conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chye Wah Yu, PhD
Organizational Affiliation
AIMST University Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
AIMST University Malaysia
City
Bedong
State/Province
Kedah
ZIP/Postal Code
08100
Country
Malaysia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Not intent to share as sponsor and stakeholders involved have to agree with this plan.
Citations:
PubMed Identifier
28219420
Citation
Coffey PS, Brown SC. Umbilical cord-care practices in low- and middle-income countries: a systematic review. BMC Pregnancy Childbirth. 2017 Feb 20;17(1):68. doi: 10.1186/s12884-017-1250-7.
Results Reference
result
PubMed Identifier
27573092
Citation
Stewart D, Benitz W; COMMITTEE ON FETUS AND NEWBORN. Umbilical Cord Care in the Newborn Infant. Pediatrics. 2016 Sep;138(3):e20162149. doi: 10.1542/peds.2016-2149.
Results Reference
result
PubMed Identifier
30971383
Citation
Leante Castellanos JL, Perez Munuzuri A, Ruiz Campillo CW, Sanz Lopez E, Benavente Fernandez I, Sanchez Redondo MD, Rite Gracia S, Sanchez Luna M. [Recommendations for the care of the umbilical cord in the newborn]. An Pediatr (Engl Ed). 2019 Jun;90(6):401.e1-401.e5. doi: 10.1016/j.anpedi.2019.01.019. Epub 2019 Apr 7. Spanish.
Results Reference
result
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Umbilical Cord Care in Term Neonates: The Role of Wondaleaf Adhesive Pouch (WLAP)
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