Neonatal Sepsis, Umbilical Cord Infection, Umbilical Sepsis
Conditions
Keywords
Umbilical cord care, Omphalitis, Neonatal sepsis, Barrier dressing
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.
Interventions
DEVICEAdhesive 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.
Sponsors
Putra Medical Centre, Malaysia
Twin Catalyst Sdn Bhd, Malaysia
AIMST University Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
Masking on participants and investigator
Eligibility
Sex/Gender
ALL
Age
1 Hours to 2 Hours
Healthy volunteers
Yes
Inclusion criteria
* Normal term neonates * Born in the study site (hospital)
Exclusion criteria
* Congenital abnormalities * Apgar score less than 7 * Neonatal conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Umbilical cord infection rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Duration of cord detachment | 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 |
Countries
Malaysia
Outcome results
None listed