Effectiveness of Alcohol 70º vs Soap on Cord Separation Time and the Complication in the Newborn

Umbilical Cord Clinical Trial

Official title:

Effectiveness of Alcohol 70º Compared With Soap on Cord Separation Time and the Complication Rate in the Newborn

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02760966
• Other study ID #: IIBSP-ALC-2015-27
• Status: Recruiting
• Phase: N/A
• First received: April 1, 2016
• Last updated: May 2, 2016
• Start date: October 2015
• Est. completion date: December 2016

Study information

• Verified date: May 2016
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Lara Perez
• Phone: +935537508
• Email: lperezrou[@]santpau.cat
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Evaluate the effectiveness of alcohol 70º compared with soap on cord separation time and the complication rate in the newborn.

Description:

Randomized clinical trial, which objective is to assess the effectiveness of 70º alcohol compared with neutral soap on the cord separation time of a selection of newborns. 34 newborns admitted to the maternity ward of the hospital have participated. The study is divided into two phases, hospital and home. The first stage is located in the hospital, where the patients who will become part of the study are chosen. After receiving the informed letting of the legal guardian the second part of this phase is started; which aim is to explain the steps to be followed to make a correct cleaning cord technique. The home phase consists of being in contact with the family through Whatsapp on the 5th day from birth, the day of the cord fall and 5 days after this fall. Making some simple questions with simple answers such as yes or no and with the possibility, or not, of sending a picture of the cord state in each follow-up visit.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 20 Days

Eligibility

Inclusion Criteria:

• Availability of legal guardians with knowledge and access to Whatsapp.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Umbilical Cord

Intervention

Other:
• Alcohol 70º

• Soap

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of cord separation	Examine the differences in the cord separation time between alcohol 70º and soap.	15 days	No
Secondary	Umbilical cord infection		28 days	No
Secondary	Omphalitis		28 days	No
Secondary	Pneumonia		28 days	No
Secondary	Diarrhea		28 days	No
Secondary	Tetanus		28 days	No
Secondary	Neonatal mortality		60 days	No
Secondary	Hospital admissions		60 days	No
Secondary	Emergency department admissions		60 days	No
Secondary	Unscheduled consultations		60 days	No