Skip to content

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02760966
Enrollment
34
Registered
2016-05-04
Start date
2015-10-31
Completion date
2016-12-31
Last updated
2016-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Umbilical Cord

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.

Interventions

OTHERAlcohol 70º
OTHERSoap

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Hours to 20 Days
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Time of cord separation15 daysExamine the differences in the cord separation time between alcohol 70º and soap.

Secondary

MeasureTime frame
Umbilical cord infection28 days
Omphalitis28 days
Pneumonia28 days
Diarrhea28 days
Tetanus28 days
Neonatal mortality60 days
Hospital admissions60 days
Emergency department admissions60 days
Unscheduled consultations60 days

Countries

Spain

Contacts

Primary ContactLara Perez
lperezrou@santpau.cat+935537508

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026