Umbilical Cord InfectionNCT07728058
Dry Cord Care Versus Alcohol Cord Care in Healthy Newborns
A study testing Routine Alcohol Cord Care and Natural Dry Cord Care in people with Umbilical Cord Infection and Newborn, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Umbilical Cord Infection, Newborn
- What is being tested?
- Routine Alcohol Cord Care and Natural Dry Cord Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Jul 2026to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
New Taipei Municipal TuCheng Hospital
New Taipei City, Taiwan, 236
TZU-MIN CHEN, RN, -886903566915, zimin0915@cgmh.org.tw
TZU-MIN CHEN, RN
About this study
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
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.
Read the 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.
- Conditions
- Umbilical Cord Infection, Newborn
- Being tested
- Routine Alcohol Cord Care, Natural Dry Cord Care
- Keywords
- Dry Cord Care, Alcohol Cord Care, Umbilical Cord, Newborn, Randomized Controlled Trial, Umbilical Cord Infection, Cord Separation Time, Bacterial Colonization, Healthcare Resource Utilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Alcohol Cord CareOther
Routine alcohol-based umbilical cord care performed according to institutional standard practice.
Natural Dry Cord CareOther
Natural dry cord care without topical antiseptics while maintaining routine hygienic care.
| Study group | Role | What they receive |
|---|---|---|
| Routine Alcohol Cord Care | Active 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. Receives: Other: Routine Alcohol Cord Care |
| Natural Dry Cord Care | Experimental | 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. Receives: Other: Natural Dry Cord Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From birth through one day after umbilical cord separation
Secondary outcomes (3)
Umbilical Cord Separation Time
Time from birth to spontaneous umbilical cord separation, recorded in days.
Measured: From birth until umbilical cord separation
Bacterial Colonization
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.
Measured: At birth before the first cord care and on Day 3 after birth
Healthcare Resource Utilization for Umbilical Cord Care
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.
Measured: From birth through hospital discharge, typically 3-4 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start7 Jul 2026
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Umbilical Cord InfectionStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- TZU-MIN CHEN, RN, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728058
- Sponsor's protocol ID
- 202600253A3
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23728678WHO 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/
PubMed 35467813
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07728058
- Acronym / sponsor ID
- 202600253A3
- Conditions
- Umbilical Cord Infection, Newborn
- Keywords
- Dry Cord Care, Alcohol Cord Care, Umbilical Cord, Newborn, Randomized Controlled Trial, Umbilical Cord Infection, Cord Separation Time, Bacterial Colonization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Alcohol Cord Care | Active comparator | Other: Routine Alcohol Cord CareNewborns 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 | Experimental | Other: Natural Dry Cord CareNewborns 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. |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine Alcohol Cord CareRoutine alcohol-based umbilical cord care performed according to institutional standard practice. | Other | Routine Alcohol Cord Care |
| Natural Dry Cord CareNatural dry cord care without topical antiseptics while maintaining routine hygienic care. | Other | Natural Dry Cord Care |
Primary outcome
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.
3 secondary outcomes
Umbilical Cord Separation Time
Time frame: From birth until umbilical cord separation
Bacterial Colonization
Time frame: At birth before the first cord care and on Day 3 after birth
Healthcare Resource Utilization for Umbilical Cord Care
Time frame: From birth through hospital discharge, typically 3-4 days after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Background: PubMed 23728678Imdad 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.
- Background: PubMed 35467813WHO 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/
- Individual participant dataSharing planned: No
Related trials for Umbilical Cord Infection
RecruitingPhase 1
Dual-Targeted Umbilical Cord Blood CAR-T Cells Against CD19 and CD22 for the Treatment of Relapsed or Refractory Acute B-Cell Lymphoblastic Leukemia
B-cell Acute Lymphoblastic Leukemia
Active, not recruitingPhase 1/2
Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With COVID-19
COVID-19 Infection
Not yet recruitingEarly Phase 1
Thermosensitive Gel Nasal Spray With Stem Cell Exosomes, Mupirocin, and DNase I for Chronic Sinusitis
Chronic Rhinosinusitis With Nasal Polyps
RecruitingPhase 1
hUC Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosishepatitis b Cirrhosis
Hepatitis B
RecruitingPhase 2
Unrelated Cord Blood Transplantation for EBV-associated Lymphoproliferative Disorders
Epstein-Barr Virus-associated Lymphoproliferative Diseases, Chronic Active Epstein-Barr Virus Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
TZU-MIN CHEN, RN principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Alcohol Cord Care and Natural Dry Cord Care in people with Umbilical Cord Infection and Newborn, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact TZU-MIN CHEN, RN (+886903566915, zimin0915@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Umbilical Cord Infection (time frame: From birth through one day after umbilical cord separation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07728058, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.