Fracture In Preterm Infants Study (FIPIN Study)

NCT04215315 | Completed

• 1 other identifier: SCH-2086
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Total number of fractures sustained by each child

  Number

  9 Months

Secondary Outcomes (1)

• Pattern (distribution) of fractures in those with fracture(s)

  9 months

Interventions

Retrospective observation OTHER

Case note and imaging review

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Using medical records

You may qualify if:

• Children (both term and preterm)up to age of 2, who have had either accidental or inflicted fractures and are otherwise healthy.

You may not qualify if:

• Children who have sustained fractures from other causes (post-surgery, post-resuscitation, metabolic bone diseases) or have any significant metabolic bone condition or received any medication known to affect vitamin D metabolism 3 months before enrolment (oral glucocorticoids, anticonvulsants etc.)

Sponsors & Collaborators

• Sheffield Children's NHS Foundation Trust: lead

Study Sites (1)

Sheffield Childrens NHS Foundation Trust

Sheffield, S10 2TH, United Kingdom

Location

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: January 2, 2020
• Study Start: October 17, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 29, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)