Umbilical CordNCT02760966
Effectiveness of Alcohol 70º vs Soap on Cord Separation Time and the Complication in the Newborn
A study testing Alcohol 70º and Soap in people with Umbilical Cord, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Evaluate the effectiveness of alcohol 70º compared with soap on cord separation time and the complication rate in the newborn. Read more about this study
- Who is it for?
- Ages 6 hours to 20 daysHealthy volunteers can take part
- Conditions the study is for
- Umbilical Cord
- What is being tested?
- Alcohol 70º and Soap
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 hours to 20 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Availability of legal guardians with knowledge and access to Whatsapp.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08026
Lara Perez, +935537508, lperezrou@santpau.cat
Lara Perez-Rouco
About this study
Official title: 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.
Read the 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.
- Conditions
- Umbilical Cord
- Being tested
- Alcohol 70º, Soap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol 70ºOther
SoapOther
Also called Jabón neutro
| Study group | Role | What they receive |
|---|---|---|
| Alcohol 70º | 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. Receives: Other: Alcohol 70º |
| Soap | 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. Receives: Other: Soap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of cord separation
Examine the differences in the cord separation time between alcohol 70º and soap.
Measured: 15 days
Secondary outcomes (9)
Umbilical cord infection
Measured: 28 days
Omphalitis
Measured: 28 days
Pneumonia
Measured: 28 days
Diarrhea
Measured: 28 days
Tetanus
Measured: 28 days
Neonatal mortality
Measured: 60 days
Hospital admissions
Measured: 60 days
Emergency department admissions
Measured: 60 days
Unscheduled consultations
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startOct 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Umbilical CordStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lara Perez, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02760966
- Sponsor's protocol ID
- IIBSP-ALC-2015-27
- Status last verified
- May 2016
- First submitted
- 1 Apr 2016
- Last updated
- 4 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Alcohol 70º Compared With Soap on Cord Separation Time and the Complication Rate in the Newborn
- ClinicalTrials.gov ID
- NCT02760966
- Acronym / sponsor ID
- IIBSP-ALC-2015-27
- Conditions
- Umbilical Cord
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 4 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcohol 70º | Experimental | Other: Alcohol 70ºUmbilical 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 | Active comparator | Other: SoapUmbilical 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. |
Who may qualify
- Ages
- 6 hours to 20 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Availability of legal guardians with knowledge and access to Whatsapp.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol 70º | Other | Alcohol 70º |
| SoapAlso: Jabón neutro | Other | Soap |
Primary outcome
Time of cord separation
Time frame: 15 days
Examine the differences in the cord separation time between alcohol 70º and soap.
9 secondary outcomes
Umbilical cord infection
Time frame: 28 days
Omphalitis
Time frame: 28 days
Pneumonia
Time frame: 28 days
Diarrhea
Time frame: 28 days
Tetanus
Time frame: 28 days
Neonatal mortality
Time frame: 60 days
Hospital admissions
Time frame: 60 days
Emergency department admissions
Time frame: 60 days
Unscheduled consultations
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lara Perez principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol 70º and Soap in people with Umbilical Cord, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lara Perez (+935537508, lperezrou@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of cord separation (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2016.