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

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

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

Conditions
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Umbilical Cord

Intervention / Treatment
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* Other: Alcohol 70º
* Other: Soap


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Hours
Maximum Age: 20 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alcohol 70º<br>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<br> <br> |
| Active Comparator: Soap<br>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<br> <br> * Other names: Jabón neutro;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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