Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03918096
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Brief Summary:

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.


Condition or disease Intervention/treatment
Premature Birth Other: Questionnaire

Layout table for study information
Study Type : Observational
Estimated Enrollment : 384 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Immunization Coverage of Premature Infants Leaving CHU d'Angers According to the Recommended Regimen During the First 4 Months (VACCIPREM)
Actual Study Start Date : April 12, 2019
Estimated Primary Completion Date : October 12, 2020
Estimated Study Completion Date : April 12, 2021

Intervention Details:
  • Other: Questionnaire
    Questionnaire to the parents after the hospital discharge


Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Child born before 37 weeks of amenorrhea
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03918096


Contacts
Layout table for location contacts
Contact: Marianne Roumy 02.41.35.63.85 ext +33 marianne.roumy@chu-angers.fr

Locations
Layout table for location information
France
CHU Angers Recruiting
Angers, France, 49933
Contact: Marianne Roumy    02.41.35.63.85 ext +33    marianne.roumy@chu-angers.fr   
Principal Investigator: Cécile Cipierre, PhD         
Sponsors and Collaborators
University Hospital, Angers

Layout table for additonal information
Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT03918096     History of Changes
Other Study ID Numbers: 2019-A00344-53
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study openning only in CHU Angers

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Angers:
vaccin

Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Vaccines
Immunologic Factors
Physiological Effects of Drugs