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

Not Applicable

• Conditions: Umbilical Cord
• Interventions: Other: Alcohol 70º; Other: Soap

• Registration Number: NCT02760966
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-04-01
• Status Verified: 2016-05
• Study First Submitted QC: 2016-05-02
• Last Update Submitted: 2016-05-02
• Study First Posted: 2016-05-04
• Last Update Posted: 2016-05-04
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 34

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alcohol 70º	Alcohol 70º	Umbilical 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	Soap	Umbilical 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.

Primary Outcome Measures

Name	Time	Method
Time of cord separation	15 days	Examine the differences in the cord separation time between alcohol 70º and soap.

Secondary Outcome Measures

Name	Time	Method
Omphalitis	28 days
Unscheduled consultations	60 days
Umbilical cord infection	28 days
Pneumonia	28 days
Diarrhea	28 days
Tetanus	28 days
Emergency department admissions	60 days
Neonatal mortality	60 days
Hospital admissions	60 days

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain