Dry Cord Care Versus Alcohol Cord Care in Healthy Newborns
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-28
SponsorChang Gung Memorial Hospital
About this trial
Umbilical cord care is an essential component of newborn care, but the optimal method remains controversial. This randomized controlled trial aims to compare routine alcohol cord care with natural dry cord care in healthy newborns. A total of 210 mother-infant dyads will be randomly assigned to either routine alcohol cord care or natural dry cord care. The primary outcome is the incidence of umbilical cord infection. Secondary outcomes include umbilical cord separation time, bacterial colonization, and healthcare resource utilization for umbilical cord care. The findings of this study will provide evidence to support optimal umbilical cord care practices for healthy newborns.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy neonates with a gestational age of 35 weeks or greater.
Birth weight of 2,300 g or greater.
Normal umbilical cord appearance at birth, with no evidence of trauma, infection, or congenital abnormalities of the umbilical cord.
Disqualifiers
Neonates born to mothers with intrapartum fever (≥38°C), clinical chorioamnionitis, or rupture of membranes for more than 18 hours
Meconium-stained amniotic fluid.
Neonates admitted directly to the Newborn Care Center (NBC) or Pediatric Intensive Care Unit (PICU) after birth.
Neonates from multiple gestations.
Trial design
Design model
Parallel
Treatments tested in this trial
Routine Alcohol Cord Care
Other interventionRoutine alcohol-based umbilical cord care performed according to institutional standard practice.
Natural Dry Cord Care
Other interventionNatural dry cord care without topical antiseptics while maintaining routine hygienic care.
Treatment groups
210 Participants
are divided into 2 treatment groupsGroup A: Routine Alcohol Cord CareActive comparator 1 intervention
Group B: Natural Dry Cord CareExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Umbilical Cord Infection
Umbilical cord infection will be assessed based on clinical signs, including redness, swelling, warmth, purulent discharge, foul odor, and abnormal body temperature. Newborns with signs suggestive of infection will be clinically evaluated, and the number and percentage of participants with umbilical cord infection will be compared between the two study groups.
Time frame
From birth through one day after umbilical cord separationSecondary outcomes
1
Umbilical Cord Separation Time
Time from birth to spontaneous umbilical cord separation, recorded in days.
Time frame
From birth until umbilical cord separation2
Bacterial Colonization
Bacterial colonization of the umbilical cord will be assessed using bacterial cultures collected at birth before the first cord care and on Day 3 after birth.
Time frame
At birth before the first cord care and on Day 3 after birth3
Healthcare Resource Utilization for Umbilical Cord Care
Healthcare resource utilization will be assessed by measuring nursing time in minutes, frequency of cord care, and cord care materials used during hospitalization. Material costs and nursing time will be compared between the two study groups.
Time frame
From birth through hospital discharge, typically 3-4 days after birthLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
New Taipei Municipal TuCheng HospitalRecruiting236, New Taipei City, Taiwan
Taiwan
TaiwanSponsors and contacts
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Source ClinicalTrials.gov