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

NCT03918096 | Completed

• 1 other identifier: 2019-A00344-53
• Study Type: observational
• Target: 384
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth

Keywords

vaccin

Outcome Measures

Primary Outcomes (1)

• Vaccination rate

  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

Interventions

Questionnaire OTHER

Questionnaire to the parents after the hospital discharge

Eligibility Criteria

• Age: Up to 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Child born before 37 weeks of amenorrhea

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

CHU Angers

Angers, 49933, France

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 17, 2019
• Study Start: April 18, 2019
• Primary Completion: May 20, 2022
• Study Completion: October 29, 2022
• Last Updated: September 22, 2023

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)