Improving Kangaroo Care to Prevent Infections in High-risk Infants in NICUs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The NeoDeco trial is a multicenter, cluster-randomized study conducted across 24 neonatal units in five European countries. It aims to implement optimized Kangaroo Care (KC) to reduce severe infections and resistant bacterial colonization among high-risk infants in neonatal intensive care units (NICUs). The study involves a baseline assessment, a wash-in period for training, and a 10-month intervention period where KC will be continuously applied. Data on clinical outcomes and bacterial colonization will be collected from all eligible infants during the study.

Why it matters

Who can join: the full rules

INCLUSION CRITERIA

1\. Site level

1a. Neonatal unit that provide routinely cares for extremely premature infants (\<28 weeks' gestation).

1b. Minimum capacity of 12 beds.

1c. Access to a -70 to -80°C freezer for storage of research samples

1d. Willing to implement optimised KC if allocated to the intervention group.

1e. Willing to commit to offering the minimum expected target duration or an increase of 50% if neonatal unit is already offering \>67% of the minimum expected target duration, if allocated to the intervention arm.

1f. Prepared to implement NeoIPC surveillance.

1. g. Adequate resources and expertise and approvals from relevant Research Ethics Committees, as appropriate.
2. Infant level

2a. All high-risk infants (born at \<32 weeks' gestation) admitted to participating neonatal units, regardless of complexity of care, anticipated hospitalisation duration, room type, or whether admitted directly after birth.

EXCLUSION CRITERIA 1 Site level

1. a. Participation in other research that could directly influence the study intervention or outcomes.
2. a. Average StSC duration already exceeding 18 hours per day.
3. a. Anticipated major changes in resistant bacterial colonisation pressure during the study

2 Infant level 2a. No infant-level exclusion criteria for data collection. We exclude infants from individual data and sample collection if their parents or legal guardians do not provide written informed consent. These infants contribute to cluster-aggregated outcomes.

Where it's running

• Aglaia Kyriakou Children's Hospital
  Athens, Greece Recruiting
• University General Hospital of Patras
  Pátrai, Greece Recruiting
• Azienda Ospedaliera Universitaria S.Anna di Ferrara
  Ferrara, Italy Recruiting
• Azienda Ospedaliera Universitaria di Modena
  Modena, Italy Recruiting
• Ospedale Universitario Policlinico Paolo Giaccone
  Palermo, Italy Recruiting
• Ospedale San Bortolo di Vicenza
  Vicenza, Italy Recruiting

Study contacts

• Study coordinator: Selene Parenti
• Email: selene.parenti@pentafoundation.org
• Phone: +39 378 309 4518

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Antibiotic Prophylaxis Before Simple Tooth Extraction in Immunosuppressed Patients with Autoimmune Rheumatic Diseases

  This trial tests whether giving a single dose of amoxicillin before a simple tooth extraction can prevent infections in adults with autoimmune rheumatic diseases who are on immunosuppressive therapy.

  Recruiting Phase 4 University of Sao Paulo General Hospital · São Paulo, São Paulo · NCT07275580

• Using Negative Pressure Therapy to Prevent Infections in Surgical Wounds

  This study is testing if using Negative Pressure Therapy can help prevent infections in surgical wounds for people who have had laparotomy surgery.

  Recruiting Gulab Devi Hospital · Lahore, Punjab Province · NCT06957964

• Identifying biomarkers for diagnosing sepsis in the emergency room

  This study is trying to find out if certain immune responses can help doctors spot sepsis in patients with infections when they arrive at the emergency room.

  Recruiting at 2 sites Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Almere Stad, Flevoland and 2 other locations · NCT06178822

• Comparing two methods to prevent infection in ACL reconstruction surgery

  This study is testing whether using grafts soaked in vancomycin can better prevent infections after ACL surgery compared to regular antibiotics for patients aged 20 to 45.

  Recruiting University of Duhok · Duhok · NCT06166381

• Molecular culture for diagnosing sepsis in children

  This study is testing a faster way to diagnose sepsis in newborns and children by using a new blood test to see if it can identify infections more quickly than the usual method.

  Recruiting at 2 sites Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Amsterdam and 1 other locations · NCT06018792

• Effect of early antibiotics on patients with out-of-hospital cardiac arrest

  This study is testing if not giving antibiotics to adults who have had a cardiac arrest outside the hospital is just as safe and effective as giving them early antibiotic treatment.

  Recruiting Hamad Medical Corporation · Doha, Baladiyat ad Dawhah · NCT05914779

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.