Newborn, Umbilical Cord Infection
Conditions
Keywords
Dry Cord Care, Alcohol Cord Care, Umbilical Cord, Newborn, Randomized Controlled Trial, Umbilical Cord Infection, Cord Separation Time, Bacterial Colonization, Healthcare Resource Utilization
Brief summary
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.
Detailed description
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.
Interventions
OTHERRoutine Alcohol Cord Care
Routine alcohol-based umbilical cord care performed according to institutional standard practice.
OTHERNatural Dry Cord Care
Natural dry cord care without topical antiseptics while maintaining routine hygienic care.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Days to 28 Days
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Umbilical Cord Infection | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Umbilical Cord Separation Time | From birth until umbilical cord separation | Time from birth to spontaneous umbilical cord separation, recorded in days. |
| Bacterial Colonization | 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. |
| Healthcare Resource Utilization for Umbilical Cord Care | 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. |
Countries
Taiwan
Contacts
CONTACTTZU-MIN CHEN, RN
PRINCIPAL_INVESTIGATORTZU-MIN CHEN, RN
Chang Gung Memorial Hospital
Outcome results
None listed