Dry Cord Care Versus Alcohol Cord Care in Healthy Newborns | NCT07728058

NCT07728058

Overview

NCT ID: NCT07728058
Lead Sponsor: Chang Gung Memorial HospitalOTHER
Official Title: Effects of Routine Umbilical Cord Care and Natural Drying Care on Neonatal Infection Rates, Cord Separation Time, and Cost-Effectiveness: A Randomized Controlled Trial
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.
Conditions: Umbilical Cord Infection

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 27, 2026Actual
Start Date: Jul 7, 2026Actual
Primary Completion Date: Apr 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 210Estimated
Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: TZU-MIN CHEN, RNContact
zimin0915@cgmh.org.tw+886903566915

Similar Studies

Participant Group/Arms

Routine Alcohol Cord CareActive Comparator

Newborns assigned to this group will receive routine alcohol-based umbilical cord care according to institutional standard practice. The assigned cord care method will be continued by caregivers after hospital discharge until umbilical cord separation.

Other: Routine Alcohol Cord Care

Natural Dry Cord CareExperimental

Newborns assigned to this group will receive natural dry cord care without the use of topical antiseptics. The assigned cord care method will be continued by caregivers after hospital discharge until umbilical cord separation.

Other: Natural Dry Cord Care