Triple Dye Plus Alcohol Versus Triple Dye Alone for Newborn Umbilical Cord Care
1 other identifier
interventional
400
1 country
1
Brief Summary
In the United States (U.S.) there currently is no standard method of umbilical cord care, resulting in varying practices within and across institutions. These differences may result in an increase in morbidities for newborns such as the formation of umbilical granulomas and increases in acute care utilization. This study will determine which of two common methods of caring for newborn umbilical cords is superior - triple dye, followed by the application of rubbing alcohol, or triple dye alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2005
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 5, 2005
CompletedFirst Posted
Study publicly available on registry
August 8, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedNovember 24, 2017
November 1, 2017
2 years
August 5, 2005
November 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine which of two common methods of caring for newborn umbilical cords is superior, triple dye followed by application of rubbing alcohol or triple dye alone
Interventions
Eligibility Criteria
You may qualify if:
- Newborn admitted to the well-baby nursery
- \>= 37 weeks gestation
- Born at Hershey Medical Center
- University Pediatric Associates patient
You may not qualify if:
- Baby with sepsis or admitted to the Neonatal Intensive Care Unit (NICU)
- \<37 weeks gestation
- Not being followed by University Pediatric Associates
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Penn State Universitylead
- Children's Miracle Networkcollaborator
Study Sites (1)
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Related Publications (3)
Golombek SG, Brill PE, Salice AL. Randomized trial of alcohol versus triple dye for umbilical cord care. Clin Pediatr (Phila). 2002 Jul-Aug;41(6):419-23. doi: 10.1177/000992280204100607.
PMID: 12166794RESULTJanssen PA, Selwood BL, Dobson SR, Peacock D, Thiessen PN. To dye or not to dye: a randomized, clinical trial of a triple dye/alcohol regime versus dry cord care. Pediatrics. 2003 Jan;111(1):15-20. doi: 10.1542/peds.111.1.15.
PMID: 12509548RESULTPezzati M, Biagioli EC, Martelli E, Gambi B, Biagiotti R, Rubaltelli FF. Umbilical cord care: the effect of eight different cord-care regimens on cord separation time and other outcomes. Biol Neonate. 2002 Jan;81(1):38-44. doi: 10.1159/000047182.
PMID: 11803175RESULT
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alawia Suliman, MD
Penn State College of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2005
First Posted
August 8, 2005
Study Start
August 1, 2005
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
November 24, 2017
Record last verified: 2017-11