New Taipei Municipal TuCheng Hospital
New Taipei City, Taiwan, 236
Location status: Recruiting
NCT Number: NCT07728058
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.
Interested in participating?
Request Info0 day–28 day
All sexes
Interventional
Not applicable
New Taipei City, Taiwan, 236
Location status: Recruiting
Umbilical cord infection remains an important cause of neonatal morbidity worldwide. Although the World Health Organization recommends dry cord care for healthy newborns born in healthcare facilities under hygienic conditions, routine alcohol cord care is still widely practiced in many hospitals. Evidence regarding the effectiveness of these two approaches in Taiwan remains limited.
This investigator-initiated, single-center, prospective, randomized controlled trial aims to compare routine alcohol cord care with natural dry cord care among healthy newborns delivered at New Taipei Municipal TuCheng Hospital. Healthy newborns who remain in the routine newborn nursery and are not admitted directly to the Newborn Care Center (NBC) or Pediatric Intensive Care Unit (PICU) will be eligible for enrollment. A total of 210 mother-infant dyads will be randomly assigned in a 1:1 ratio to either routine alcohol cord care or natural dry cord care using computer-generated randomization.
Newborns assigned to the routine alcohol cord care group will receive standard alcohol-based umbilical cord care according to institutional practice. Newborns assigned to the natural dry cord care group will receive dry cord care without topical antiseptics while maintaining routine hygienic care.
The primary outcome is the incidence of umbilical cord infection. Secondary outcomes include umbilical cord separation time,bacterial colonization assessed using bacterial cultures, and healthcare resource utilization for umbilical cord care, including nursing time, frequency of cord care, cord care materials, and associated costs.Umbilical cord status and clinical signs of infection will be assessed daily during hospitalization. After discharge, caregivers will continue follow-up assessments by submitting standardized photographs of the umbilical cord to a secure study-specific LINE group until one day after cord separation.
This study is expected to provide high-quality clinical evidence regarding the effectiveness, safety, and healthcare resource utilization associated with natural dry cord care compared with routine alcohol cord care and may contribute to future evidence-based neonatal cord care recommendations.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Routine alcohol-based umbilical cord care performed according to institutional standard practice.
Natural dry cord care without topical antiseptics while maintaining routine hygienic care.
Time frame: From birth through one day after umbilical cord separation
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 until umbilical cord separation
Time from birth to spontaneous umbilical cord separation, recorded in days.
Time frame: At birth before the first cord care and on Day 3 after birth
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: From birth through hospital discharge, typically 3-4 days after birth
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.
Contact information is provided by the study sponsor or research team.
Chang Gung Memorial Hospital
Other
Effects of Routine Umbilical Cord Care and Natural Drying Care on Neonatal Infection Rates, Cord Separation Time, and Cost-Effectiveness: A Randomized Controlled Trial
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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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