Dry Cord Care Versus Alcohol Cord Care in Healthy Newborns
Effects of Routine Umbilical Cord Care and Natural Drying Care on Neonatal Infection Rates, Cord Separation Time, and Cost-Effectiveness: A Randomized Controlled Trial
1 other identifier
interventional
210
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 7, 2026
CompletedFirst Submitted
Initial submission to the registry
July 13, 2026
CompletedFirst Posted
Study publicly available on registry
July 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
July 27, 2026
July 1, 2026
1.7 years
July 13, 2026
July 22, 2026
Conditions
Keywords
Outcome Measures
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.
From birth through one day after umbilical cord separation
Secondary Outcomes (3)
Umbilical Cord Separation Time
From birth until umbilical cord separation
Bacterial Colonization
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
Study Arms (2)
Routine Alcohol Cord Care
ACTIVE COMPARATORNewborns 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.
Natural Dry Cord Care
EXPERIMENTALNewborns 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.
Interventions
Routine alcohol-based umbilical cord care performed according to institutional standard practice.
Natural dry cord care without topical antiseptics while maintaining routine hygienic care.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New Taipei Municipal TuCheng Hospital
New Taipei City, Taiwan, 236, Taiwan
Related Publications (2)
Imdad A, Bautista RM, Senen KA, Uy ME, Mantaring JB 3rd, Bhutta ZA. Umbilical cord antiseptics for preventing sepsis and death among newborns. Cochrane Database Syst Rev. 2013 May 31;2013(5):CD008635. doi: 10.1002/14651858.CD008635.pub2.
PMID: 23728678BACKGROUNDWHO recommendations on maternal and newborn care for a positive postnatal experience [Internet]. Geneva: World Health Organization; 2022. Available from http://www.ncbi.nlm.nih.gov/books/NBK579657/
PMID: 35467813BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
TZU-MIN CHEN, RN
Chang Gung Memorial Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2026
First Posted
July 27, 2026
Study Start
July 7, 2026
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
July 27, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share