Evaluation of Immunization Coverage of Premature Infants Leaving CHU d'Angers According to the Recommended Regimen During the First 4 Months (VACCIPREM) (VACCIPREM)

September 21, 2023 updated by: University Hospital, Angers

Premature children are particularly vulnerable in terms of infection and vaccinated in a specific, reinforced vaccination schedule. However, the beginning of the vaccination of these children is often postponed and the vaccination schedule little followed.Concerning the vaccination of premature children, the national recommendations of the High Council of Public Health (HCSP) are different from those of the French experts in pediatric vaccinology. The HCSP recommends a vaccination schedule beginning at the age of 8 weeks postnatal, including, as for full-term infants, two injections at 2-month intervals of vaccine against diphtheria, tetanus, poliomyelitis, haemophilus influenzae B type, whooping cough and hepatitis B. Anti-pneumococcal vaccination is recommended at 2, 3 and 4 months of life.

The French experts of the Infectious Pediatric Pathology Group (GPIP) of the French Pediatric Society recommend a primary vaccination against whooping cough, diphtheria, tetanus, poliomyelitis, Haemophilus Influenzae B (DTPCoqHIB) and hepatitis B at 2, 3 and 4 months for children born before 33 weeks of amenorrhea (WA), and at 2 and 4 months for those born between 33 and 36 weeks + 6 days. Primary anti-pneumococcal vaccination is recommended at 2, 3 and 4 months for all children born prematurely before 37WA.

On the other hand, the cocooning vaccination of the parents against whooping cough is recommended in case of birth at term as of premature birth. This cocooning strategy has not been sufficiently applied, justifying a recall in 2008 for all adults who have not received pertussis vaccination during the last ten years.

The investigators seek to evaluate the follow-up of the recommended vaccination schedule of premature children leaving Angers University Hospital and the reasons associated with the non-monitoring of the calendar in order to identify possible lines of work to improve immunization compliance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

384

Contacts and Locations

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

Study Contact

Study Locations

  • France
      • Angers, France, 49933
        • CHU Angers

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

No older than 1 week (Child)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Child born before 37 weeks of amenorrhea

Description

Inclusion Criteria:

  • Child born before 37 weeks of amenorrhea
  • Child hospitalized in resuscitation and neonatalogy unity of Angers Hospital

Exclusion Criteria:

  • Child transfered to an another unity before to go home
  • Child without french parents

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaccination rate
Time Frame: 24 month
To evaluate in premature children, the vaccination rate according to the recommendations of the French experts in pediatric vaccinology during the first 4 months of life.
24 month

Collaborators and Investigators

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

Sponsor

University Hospital, Angers

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 (Actual)

April 18, 2019

Primary Completion (Actual)

May 20, 2022

Study Completion (Actual)

October 29, 2022

Study Registration Dates

First Submitted

April 12, 2019

First Submitted That Met QC Criteria

April 12, 2019

First Posted (Actual)

April 17, 2019

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-A00344-53

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study openning only in CHU Angers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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