Infants Aged One Month to 2 Years , Infants With Any Type of Feeding (Breast or Artificial or Weaned Attend Assiut University Children Hospital )NCT03283215
Causes and Underlying Factors of Faltering Growth Among Infants
An observational study of Infants Aged One Month to 2 Years , Infants With Any Type of Feeding (Breast or Artificial or Weaned Attend Assiut University Children Hospital ), run by Assiut University.
Trial summary
to research in the different causes of failure to thrive in children including organic and non organic causes Read more about this study
- Who is it for?
- Ages 1 month to 2 years
- Conditions the study is for
- Infants Aged One Month to 2 Years , Infants With Any Type of Feeding (Breast or Artificial or Weaned Attend Assiut University Children Hospital )
- What is being tested?
- complete blood count , electrolytes
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2017to 30 Sep 2018
- 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 1 month to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: infants aged 1month upto 2 years infants with any type of feeding (breast , artificial or weaned)
Who may be able to join
- :Infants attending assiut university children hospital who are stunting(decrease height for age ), wasting(decrease weight for lenght ), and underweight (decreases weight for age ) . When all of theses less than -1 Z scores (normal Z-score from -1 to +1 ) . Also mid arm circumference below than 115 mm
Who cannot join
- Children complaining of any of the follolowing:
- Malignancy
About this study
to research in the different causes of failure to thrive in children including organic and non organic causes
Read the detailed description
Altered growth velocity in infants has been traditionally described by the term (failure to thrive ) . More recently the preferred terms are faltering growth ,slow weight gain or undernourishment as failure to thrive has been associated with negative connotations of parents failing in their job as careproviders.
The expression 'to falter' means to hesitate. Faltering growth is an observation,without value judgement, of slower than expected rate of growth along an infant's previously defined growth curve.
Faltering growth is a common pediatric problem with many untoward effects . More studies showed that children who failed to thrive in infancy are lighter and shorter at school age with adverse intellectual outcomes (corbett and drewett,2004)(Natale etal., 2014). Weight faltering in the first months of life is particularly associated with these adverse effects.
Infants with faltering growth also have a higher prevalence of feeding problems (Young etal., 2013).Growth failure is more common during infancy than during any other stage of life because programmed growth rates and nutritional needs are high (
- Being tested
- complete blood count , electrolytes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
complete blood count , electrolytesDiagnostic test
Also called urine analysis
it is a labarotory test to assess hemoglobin white blood count plate let
What is being measured
The primary outcome is the main question the study is designed to answer.
to recognize nutritional causes of faltering growth
- recognize nutritional causes of faltering growth by measuring weight ,height ,mid arm circumference ,skin fold thickness
Measured: from october 2017 to september 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start1 Oct 2017 (estimated)
- Primary completion30 Sep 2018 (estimated)
- Study completion30 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infants Aged One Month to 2 Years , Infants With Any Type of Feeding (Breast or Artificial or Weaned Attend Assiut University Children Hospital )Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, marina asem shafic, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03283215
- Sponsor's protocol ID
- IRB00008717
- Status last verified
- Aug 2017
- First submitted
- 29 Aug 2017
- Last updated
- 15 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Causes and Underlying Factors of Faltering Growth Among Infants
- ClinicalTrials.gov ID
- NCT03283215
- Acronym / sponsor ID
- IRB00008717
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 14 Sep 2017 (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.
to research in the different causes of failure to thrive in children including organic and non organic causes
Detailed description
Altered growth velocity in infants has been traditionally described by the term (failure to thrive ) . More recently the preferred terms are faltering growth ,slow weight gain or undernourishment as failure to thrive has been associated with negative connotations of parents failing in their job as careproviders.
The expression 'to falter' means to hesitate. Faltering growth is an observation,without value judgement, of slower than expected rate of growth along an infant's previously defined growth curve.
Faltering growth is a common pediatric problem with many untoward effects . More studies showed that children who failed to thrive in infancy are lighter and shorter at school age with adverse intellectual outcomes (corbett and drewett,2004)(Natale etal., 2014). Weight faltering in the first months of life is particularly associated with these adverse effects.
Infants with faltering growth also have a higher prevalence of feeding problems (Young etal., 2013).Growth failure is more common during infancy than during any other stage of life because programmed growth rates and nutritional needs are high (
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- infants aged 1month upto 2 years infants with any type of feeding (breast , artificial or weaned)
Key inclusion criteria (1 listed)
- :Infants attending assiut university children hospital who are stunting(decrease height for age ), wasting(decrease weight for lenght ), and underweight (decreases weight for age ) . When all of theses less than -1 Z scores (normal Z-score from -1 to +1 ) . Also mid arm circumference below than 115 mm
Key exclusion criteria (2 listed)
- Malignancy
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 |
|---|---|---|
| complete blood count , electrolytesAlso: urine analysisit is a labarotory test to assess hemoglobin white blood count plate let | Diagnostic test | – |
Primary outcome
to recognize nutritional causes of faltering growth
Time frame: from october 2017 to september 2018
o recognize nutritional causes of faltering growth by measuring weight ,height ,mid arm circumference ,skin fold thickness
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Infants Aged One Month to 2 Years , Infants With Any Type of Feeding (Breast or Artificial or Weaned Attend Assiut University Children Hospital ), run by Assiut University.
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 2 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: status not confirmed, as of the sponsor's last update on 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
to recognize nutritional causes of faltering growth (time frame: from october 2017 to september 2018). 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 15 Sep 2017.