Fractures, BoneNCT04215315
Fracture In Preterm Infants Study (FIPIN Study)
An observational study of Fractures, Bone, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Fractures, Bone
- What is being tested?
- Retrospective observation
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Oct 2017to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: Using medical records
Who may be able to join
- Children (both term and preterm)up to age of 2, who have had either accidental or inflicted fractures and are otherwise healthy.
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Childrens NHS Foundation Trust
Sheffield, S10 2TH
About this study
Official title: Prevalence and Characteristics of Fractures in Preterm Infants Presenting to Accident and Emergency: A Retrospective Study.
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.
Read the detailed description
This is a retrospective study involving only data collection and no patient contact.
Data will be collected from both Sheffield Children's Hospital Accident and Emergency Department and Jessop Hospital. The coding office will be contacted for a list of children below the age of 2 presenting to SCH with a fracture from January 2005 to December 2015, and a list of children born in Jessop Hospital over the same time period. By comparing both lists and selecting the matching cohort, we will have a list of those children (below the age of 2, preterm or term) born in Jessop Hospital who presented to SCH with a fracture over the last 10 years. The clinical notes of these patients will be accessed electronically and through their clinical files.
Data collection
Jessop:
A consultant employed by Jessop hospital or with the appropriate HR arrangement with the Trust will retrieve numbers of all pre-term babies born between Jan 2005 and Dec 2014 from the Jessop database and collect the data.
SCH:
A named researcher will retrieve NHS numbers of all children( both term and pre-term) less than 2 years of age presenting with a fracture between Jan 2005 and Dec 2014 from Sheffield Children's Hospital Coding Office and collect the data.
The PI of the study will cross match both records and identify the common cohort and assign one patient study identification number for each NHS number which should be used across both sites.
A named researcher will collect data from both Sheffield Children's Hospital Accident and Emergency Department and Jessop Hospital as outlined above.
Statistical analysis will be performed using SPSS. Descriptive for age, sex, gestation, ethnicity, and diagnosis; Chi-square for categorical data, with the possibility of regression analysis on advice of a statistician.
- Conditions
- Fractures, Bone
- Being tested
- Retrospective observation
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective observationOther
Case note and imaging review
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of fractures sustained by each child
Number
Measured: 9 Months
Secondary outcomes (1)
Pattern (distribution) of fractures in those with fracture(s)
Number per bone
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start17 Oct 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures, BoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215315
- Sponsor's protocol ID
- SCH-2086
- Status last verified
- Jan 2020
- First submitted
- 23 Apr 2018
- Last updated
- 29 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Characteristics of Fractures in Preterm Infants Presenting to Accident and Emergency: A Retrospective Study.
- ClinicalTrials.gov ID
- NCT04215315
- Acronym / sponsor ID
- SCH-2086
- Conditions
- Fractures, Bone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a retrospective study involving only data collection and no patient contact.
Data will be collected from both Sheffield Children's Hospital Accident and Emergency Department and Jessop Hospital. The coding office will be contacted for a list of children below the age of 2 presenting to SCH with a fracture from January 2005 to December 2015, and a list of children born in Jessop Hospital over the same time period. By comparing both lists and selecting the matching cohort, we will have a list of those children (below the age of 2, preterm or term) born in Jessop Hospital who presented to SCH with a fracture over the last 10 years. The clinical notes of these patients will be accessed electronically and through their clinical files.
Data collection
Jessop:
A consultant employed by Jessop hospital or with the appropriate HR arrangement with the Trust will retrieve numbers of all pre-term babies born between Jan 2005 and Dec 2014 from the Jessop database and collect the data.
SCH:
A named researcher will retrieve NHS numbers of all children( both term and pre-term) less than 2 years of age presenting with a fracture between Jan 2005 and Dec 2014 from Sheffield Children's Hospital Coding Office and collect the data.
The PI of the study will cross match both records and identify the common cohort and assign one patient study identification number for each NHS number which should be used across both sites.
A named researcher will collect data from both Sheffield Children's Hospital Accident and Emergency Department and Jessop Hospital as outlined above.
Statistical analysis will be performed using SPSS. Descriptive for age, sex, gestation, ethnicity, and diagnosis; Chi-square for categorical data, with the possibility of regression analysis on advice of a statistician.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Using medical records
Key inclusion criteria (1 listed)
- Children (both term and preterm)up to age of 2, who have had either accidental or inflicted fractures and are otherwise healthy.
Key exclusion criteria (1 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrospective observationCase note and imaging review | Other | – |
Primary outcome
Total number of fractures sustained by each child
Time frame: 9 Months
Number
1 secondary outcome
Pattern (distribution) of fractures in those with fracture(s)
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fractures, Bone, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of fractures sustained by each child (time frame: 9 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020.