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NCT Number: NCT07728058

Dry Cord Care Versus Alcohol Cord Care in Healthy Newborns

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.

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Key information

Age range

0 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New Taipei Municipal TuCheng Hospital

New Taipei City, Taiwan, 236

Location status: Recruiting

Location contact

TZU-MIN CHEN, RN

CONTACT

[email protected]

-886903566915

TZU-MIN CHEN, RN

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Routine Alcohol Cord Care

Other

Routine alcohol-based umbilical cord care performed according to institutional standard practice.

Natural Dry Cord Care

Other

Natural dry cord care without topical antiseptics while maintaining routine hygienic care.

Primary outcomes

  1. Incidence of Umbilical Cord Infection

    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.

Secondary outcomes

  1. Umbilical Cord Separation Time

    Time frame: From birth until umbilical cord separation

    Time from birth to spontaneous umbilical cord separation, recorded in days.

  2. Bacterial Colonization

    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.

  3. Healthcare Resource Utilization for Umbilical Cord Care

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

TZU-MIN CHEN, RN

CONTACT

[email protected]

+886903566915

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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