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

Neonatal Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05569551
• Other study ID #: AURRB/IND/TWIN/2020/01
• Status: Completed
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: September 16, 2023

Study information

• Verified date: January 2024
• Source: AIMST University Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: September 16, 2023
• Est. primary completion date: August 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Hour to 2 Hours

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Neonatal Sepsis
• Sepsis
• Toxemia

Intervention

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.

Locations

Country	Name	City	State
Malaysia	AIMST University Malaysia	Bedong	Kedah

Sponsors (3)

Lead Sponsor	Collaborator
AIMST University Malaysia	Putra Medical Centre, Malaysia, Twin Catalyst Sdn Bhd, Malaysia

Country where clinical trial is conducted

Malaysia, 

References & 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. — View 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):40 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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