Umbilical Cord Care in Term Neonates: The Role of Wondaleaf Adhesive Pouch (WLAP)

Umbilical Cord Care in Term Neonates: The Revolutionized Role of Wondaleaf Adhesive Pouch (WLAP) in the Prevention of Neonatal Sepsis

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.

Study Overview

• Status: Completed
• Conditions: Neonatal Sepsis; Umbilical Cord Infection; Umbilical Sepsis
• Intervention / Treatment: Device: Adhesive pouch

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.

• Study Type: Interventional
• Enrollment (Actual): 218
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kedah
    • Bedong, Kedah, Malaysia, 08100
      • AIMST University Malaysia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 2 hours (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Normal term neonates
• Born in the study site (hospital)

Exclusion Criteria:

• Congenital abnormalities
• Apgar score less than 7
• Neonatal conditions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adhesive pouch; Experimental group will be applied with Wondaleaf adhesive pouch to cover up the umbilical stump	Device: Adhesive pouch; 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.; Other Names: Wondaleaf adhesive pouch (WLAP)
No Intervention: Conventional care; Control group will not be applied with Wondaleaf adhesive pouch, but the umbilical stump is managed with conventional care, by cleaning with antiseptic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From the date of randomization until the date of cord infection occurred, assessed up to 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From date of randomization until the date of cord detached, assessed up to 2 weeks

Collaborators and Investigators

• Sponsor: AIMST University Malaysia
• Collaborators: Putra Medical Centre, Malaysia; Twin Catalyst Sdn Bhd, Malaysia
• Investigators: Principal Investigator: Chye Wah Yu, PhD, AIMST University Malaysia

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Actual): August 16, 2023
• Study Completion (Actual): September 16, 2023

Study Registration Dates

• First Submitted: September 25, 2022
• First Submitted That Met QC Criteria: October 4, 2022
• First Posted (Actual): October 6, 2022

Study Record Updates

• Last Update Posted (Actual): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Omphalitis; Neonatal sepsis; Umbilical cord care; Barrier dressing
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Sepsis; Toxemia; Neonatal Sepsis
• Other Study ID Numbers: AURRB/IND/TWIN/2020/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not intent to share as sponsor and stakeholders involved have to agree with this plan.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No