Clinical trial NCT05569551: 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
Overall status: COMPLETED
Phase: NA
Conditions: Umbilical Cord Infection
Umbilical Sepsis
Neonatal Sepsis
Keywords: Umbilical cord care
Omphalitis
Neonatal sepsis
Barrier dressing
Lead sponsor: AIMST University Malaysia
Sponsor class: OTHER
Collaborators: name: Putra Medical Centre, Malaysia
name: Twin Catalyst Sdn Bhd, Malaysia
First posted: 2022-10-06
Enrollment: 218
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Umbilical cord infection rate
timeFrame: From the date of randomization until the date of cord infection occurred, assessed up to 3 weeks
Secondary outcomes:
measure: Duration of cord detachment
timeFrame: From date of randomization until the date of cord detached, assessed up to 2 weeks
Other outcomes:
Locations:
city: Bedong
country: Malaysia
facility: AIMST University Malaysia
state: Kedah
Study officials:
affiliation: AIMST University Malaysia
name: Chye Wah Yu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.