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Completed

NCT Number: NCT05569551

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

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.

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Key information

Conditions

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

Age range

1 hour–2 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AIMST University Malaysia

Bedong, Kedah, 08100, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Other names: Wondaleaf adhesive pouch (WLAP)

Primary outcomes

  1. Umbilical cord infection rate

    Time frame: From the date of randomization until the date of cord infection occurred, assessed up to 3 weeks

    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 outcomes

  1. Duration of cord detachment

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

    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

Sponsors and collaborators

Lead sponsor

AIMST University Malaysia

Other

Collaborators

  • Putra Medical Centre, Malaysia
  • Twin Catalyst Sdn Bhd, Malaysia

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 6, 2022
Registry last updated
Jan 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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