Effectiveness of Alcohol 70º vs Soap on Cord Separation Time and the Complication in the Newborn
Effectiveness of Alcohol 70º Compared With Soap on Cord Separation Time and the Complication Rate in the Newborn
1 other identifier
interventional
34
1 country
1
Brief Summary
Evaluate the effectiveness of alcohol 70º compared with soap on cord separation time and the complication rate in the newborn.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2015
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
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 1, 2016
CompletedFirst Posted
Study publicly available on registry
May 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMay 4, 2016
May 1, 2016
1.2 years
April 1, 2016
May 2, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Time of cord separation
Examine the differences in the cord separation time between alcohol 70º and soap.
15 days
Secondary Outcomes (9)
Umbilical cord infection
28 days
Omphalitis
28 days
Pneumonia
28 days
Diarrhea
28 days
Tetanus
28 days
- +4 more secondary outcomes
Study Arms (2)
Alcohol 70º
EXPERIMENTALUmbilical cord care will be carried out using alcohol 70º at least 3 times a day. Firstly, there must be a proper hand hygiene. Then, with sterile gauzes alcohol will be applied from the abdominal part to the end of the stump.
Soap
ACTIVE COMPARATORUmbilical cord care will be carried out using soap at least 3 times a day. Firstly, there must be a proper hand hygiene. Then, with sterile gauzes alcohol will be applied from the abdominal part to the end of the stump.
Interventions
Eligibility Criteria
You may qualify if:
- Availability of legal guardians with knowledge and access to Whatsapp.
You may not qualify if:
- Admission in the newborn's room.
- Patients with strong concomitant illness, that limits the planned activities or whose current state contraindicates the incorporation of the program.
- Mother's age \< 18 years old.
- Bad controlled mother's diabetes (at least two digits of blood glucose \<180 mg/dl per day), bad alimentation control and/or non-adherence.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08026, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lara Perez
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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
April 1, 2016
First Posted
May 4, 2016
Study Start
October 1, 2015
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
May 4, 2016
Record last verified: 2016-05