Suspended

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

What is being tested

Alcohol 70º

+ Soap

Other

Who is being recruted

+5 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Interventional

Study Start: October 2015

See protocol details

Summary

Principal SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study ContactLara Perez

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2015

Actual date on which the first participant was enrolled.

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.

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

NCT02760966

Principal SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study ContactLara Perez

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

34 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

1 inclusion criteria required to participate

Availability of legal guardians with knowledge and access to Whatsapp.

4 exclusion criteria prevent from participating

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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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.

Group II

Active Comparator

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Hospital de la Santa Creu i Sant Pau

Barcelona, SpainOpen Hospital de la Santa Creu i Sant Pau in Google Maps

SuspendedOne Study Center