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Fracture In Preterm Infants Study (FIPIN Study)

NCT04215315 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2020-01-29

No results posted yet for this study

Summary

Children who are born early (pre-term infants) are at increased risk of fractures until the age of 2 years, due to their weak bones caused by several physiological, and environmental factors.There is however little information about the persistence of this increased risk of fractures in childhood. There is also lack of detail in the medical literature about the gestational age at birth of children presenting to hospitals with fractures, the nature of their fractures and the differences in fracture features, if any, between the preterm and term (infants born at 37 weeks and above) children. This information would be especially useful for doctors when deciding if a fracture with no other obvious explanation in a preterm child is caused by an accidental or inflicted injury.

This dilemma is complicated by reports that preterm children are more likely to be subjected to abuse as compared to term children. Furthermore, infants less than a year old are more likely to be abused, and this coincides with the time when preterm infants are most vulnerable. Hence it is important to collect information about the physical examination, chemical substances in their blood and x-ray features of fractures in preterm children. Also important to study is whether there are differences in how accidental and inflicted fractures present in term and preterm children, as certain findings in term children might not apply in the context of prematurity. Determining if preterm birth is a major cause for childhood fractures is also especially relevant to the medico legal profession. When there is a suspected inflicted fracture in an ex-preterm child, the outcome could depend on whether prematurity is an adequate explanation for fractures. We would like to collect, study and present detailed information on the differences in causes and patterns of accidental and inflicted fractures in both preterm and term children. This could lend support to medical opinions offered in medico legal proceedings in which child abuse is alleged in preterm infants.

Conditions

  • Fractures, Bone

Interventions

OTHER

Retrospective observation

Case note and imaging review

Sponsors & Collaborators

  • Sheffield Children's NHS Foundation Trust

    lead OTHER

Eligibility

Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-17
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04215315 on ClinicalTrials.gov