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

May 2, 2016 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08026
        • Recruiting
        • Hospital De La Santa Creu I Sant Pau
        • Contact:
        • Principal Investigator:
          • Lara Perez-Rouco
        • Sub-Investigator:
          • Ana Lopez-Arigüel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 hours to 2 weeks (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Other: Alcohol 70º
ACTIVE_COMPARATOR: 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.
Other: Soap
Other Names:
  • Jabón neutro

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of cord separation
Time Frame: 15 days
Examine the differences in the cord separation time between alcohol 70º and soap.
15 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Umbilical cord infection
Time Frame: 28 days
28 days
Omphalitis
Time Frame: 28 days
28 days
Pneumonia
Time Frame: 28 days
28 days
Diarrhea
Time Frame: 28 days
28 days
Tetanus
Time Frame: 28 days
28 days
Neonatal mortality
Time Frame: 60 days
60 days
Hospital admissions
Time Frame: 60 days
60 days
Emergency department admissions
Time Frame: 60 days
60 days
Unscheduled consultations
Time Frame: 60 days
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Lara Perez, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

April 1, 2016

First Submitted That Met QC Criteria

May 2, 2016

First Posted (ESTIMATE)

May 4, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

May 4, 2016

Last Update Submitted That Met QC Criteria

May 2, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • IIBSP-ALC-2015-27

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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