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

NCT05569551 | Completed

• 1 other identifier: AURRB/IND/TWIN/2020/01
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

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.

Conditions

Umbilical Cord Infection; Umbilical Sepsis; Neonatal Sepsis

Keywords

Umbilical cord care; Omphalitis; Neonatal sepsis; Barrier dressing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Duration of cord detachment

  From date of randomization until the date of cord detached, assessed up to 2 weeks

Study Arms (2)

Adhesive pouch

EXPERIMENTAL

Experimental group will be applied with Wondaleaf adhesive pouch to cover up the umbilical stump

Device: Adhesive pouch

Conventional care

NO INTERVENTION

Control group will not be applied with Wondaleaf adhesive pouch, but the umbilical stump is managed with conventional care, by cleaning with antiseptic.

Interventions

Adhesive pouch DEVICE

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.

Also known as: Wondaleaf adhesive pouch (WLAP)

Adhesive pouch

Eligibility Criteria

• Age: 1 Hour - 2 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• AIMST University Malaysia: lead
• Putra Medical Centre, Malaysia: collaborator
• Twin Catalyst Sdn Bhd, Malaysia: collaborator

Study Sites (1)

AIMST University Malaysia

Bedong, Kedah, 08100, Malaysia

Location

Related Publications (3)

• 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.

  PMID: 28219420 RESULT

• 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.

  PMID: 27573092 RESULT

• 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.

  PMID: 30971383 RESULT

MeSH Terms

Conditions

Neonatal Sepsis

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chye Wah Yu, PhD

  AIMST University Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Masking on participants and investigator
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 25, 2022
• First Posted: October 6, 2022
• Study Start: November 15, 2022
• Primary Completion: August 16, 2023
• Study Completion: September 16, 2023
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)