Neonatal HypoglycemiaNCT05977972
Pattern of Metabolic Causes of Neonatal Hypoglycemia
An observational study of Neonatal Hypoglycemia and Metabolic Disease, run by Assiut University.
Trial summary
Inborn errors of metabolism (IEM) are disorders in which there is a block at some point in the normal metabolic pathway caused by a genetic defect of a specific enzyme. The number of diseases in humans known to be attributable to inherited point defects in metabolism now exceeds 500.While the diseases individually are… Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Neonatal Hypoglycemia, Metabolic Disease
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 1 Aug 2024
- 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 day to 28 days
- All sexes
- Child
Study population: Any Neonate aged 1 day to 28 days admitted to NICU during one and half year period fulfilling the inclusion criteria.
Who may be able to join
- Age: 1day to 28 days .
- Sex : Both genders .
- Full Term infant ≥ 37 completed weeks.
- Persistent hypoglycemia (Blood glucose level ≤ 45 mg/dl/2,5 mmol /L) for more than one reading and not responding to IV fluids and /or oral feeding.
Who cannot join
- Age more than 28 days.
- Newborn with surgical problems.
About this study
Official title: Pattern of Metabolic Causes of Neonatal Hypoglycemia at Assiut University Children's Hospital
Inborn errors of metabolism (IEM) are disorders in which there is a block at some point in the normal metabolic pathway caused by a genetic defect of a specific enzyme. The number of diseases in humans known to be attributable to inherited point defects in metabolism now exceeds 500.While the diseases individually are rare, they collectively account for a significant proportion of neonatal and childhood morbidity and mortality. Diagnosis is important not only for treatment and prognostication but also for genetic counselling and antenatal diagnosis in subsequent pregnancies.
Read the detailed description
Inborn errors of metabolism (IEM) are disorders in which there is a block at some point in the normal metabolic pathway caused by a genetic defect of a specific enzyme. The number of diseases in humans known to be attributable to inherited point defects in metabolism now exceeds 500.While the diseases individually are rare, they collectively account for a significant proportion of neonatal and childhood morbidity and mortality. Diagnosis is important not only for treatment and prognostication but also for genetic counselling and antenatal diagnosis in subsequent pregnancies.So ,the main problems facing the physician caring for a sick newborn infant are to know when to consider the possibility of a metabolic disorder, what to do to determine quickly and efficiently whether a child has a metabolic disease, and how to treat the patient until a diagnosis is established.
One of the clinical presentations that raises red flags of inborn error of metabolism is persistent or recurrent hypoglycemia. However recognizing hypoglycemia in the newborn may be difficult, because the symptoms of hypoglycemia (i.e., lethargy, poor feeding, hypothermia, and seizures) are non specific. Frequent blood sugar determinations are often required to confirm the suspicion of hypoglycemia. Because inborn errors of metabolism are a relatively infrequent cause of neonatal hypoglycemia, other diagnostic possibilities should be investigated concurrently.
The first possibility to consider is neonatal stress secondary to perinatal asphyxia, hypothermia, or intrauterine malnutrition (e.g., placental abnormalities, prematurity, multiple gestations). The second consideration is the possibility of a hormonal abnormality affecting insulin regulation. The inborn errors of metabolism associated with insulin dysregulation include 3-hydroxacyl-CoA dehydrogenase (HADH ) deficiency and hyperammonemia/hyperinsulinism (HA/HI) syndrome, both of which are diazoxide-responsive.The third possibility to consider is a malformation syndrome, specifically including those syndromes associated with hormonal dysregulation such as Beckwith-Wiedemann syndrome. The fourth possibility is that the patient has a severe hepatocellular or cirrhotic liver disease that leads non specifically to fasting hypoglycemia.
Hypoglycemia may be associated with five categories of inborn errors of metabolism: fatty acid oxidation defects gluconeogenesis defects, glycogen storage diseases, ketogenesis defects, and organic acidemias . The diagnostic approach to hypoglycemia, therefore, must give consideration to entities belonging to each of these categories. Usually, Krebs cycle defects and mitochondrial disorders do not produce hypoglycemia, but these defects should be considered when other evidence points in their direction.
The diagnostic approach must quickly narrow the field of possible diagnoses so that specific treatment can be instituted. The classic approaches to the differential diagnosis of hypoglycemic disorders in children are the fasting study and specialized challenge tests. These studies are, however, not feasible in newborn infants because of the significant risks and technical difficulties associated with performing such studies and because of the lack of control data derived from normal neonates. Alternatively, efforts to determine the cause of hypoglycemia in the newborn infant should include hormonal and biochemical studies before and after feeding and especially during an acute episode of hypoglycemia. Definitive diagnosis might have to be postponed several months until the child is old enough to tolerate a formal fasting study or specialized in vitro cell studies.
An algorithm for diagnosing the disorders that cause neonatal hypoglycemia can be generated from the results of the following studies: blood electrolytes and pH, plasma and urinary ketones, plasma free fatty acids, blood lactate and pyruvate, blood ammonia, liver function tests, plasma and urinary carnitine and acylcarnitine analysis, and urinary organic acids. A specific diagnosis might not be made by these studies, but they are necessary for providing a provisional diagnosis that can be confirmed by specific enzyme analysis.
- Conditions
- Neonatal Hypoglycemia, Metabolic Disease
- Medical subject headings
- Metabolic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Pattern of metabolic diseases in neonates with hypoglycemia
Detection of Pattern of metabolic diseases in neonates with hypoglycemia who admitted to Neonatal Intensive Care Unit NICU at Assiut University Children's Hospital
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal HypoglycemiaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Mohammed Bakry Hassan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977972
- Sponsor's protocol ID
- Neonatal hypoglycemia
- Status last verified
- Jul 2023
- First submitted
- 24 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern of Metabolic Causes of Neonatal Hypoglycemia at Assiut University Children's Hospital
- ClinicalTrials.gov ID
- NCT05977972
- Acronym / sponsor ID
- Neonatal hypoglycemia
- Conditions
- Neonatal Hypoglycemia, Metabolic Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 7 Aug 2023 (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.
Inborn errors of metabolism (IEM) are disorders in which there is a block at some point in the normal metabolic pathway caused by a genetic defect of a specific enzyme. The number of diseases in humans known to be attributable to inherited point defects in metabolism now exceeds 500.While the diseases individually are rare, they collectively account for a significant proportion of neonatal and childhood morbidity and mortality. Diagnosis is important not only for treatment and prognostication but also for genetic counselling and antenatal diagnosis in subsequent pregnancies.
Detailed description
Inborn errors of metabolism (IEM) are disorders in which there is a block at some point in the normal metabolic pathway caused by a genetic defect of a specific enzyme. The number of diseases in humans known to be attributable to inherited point defects in metabolism now exceeds 500.While the diseases individually are rare, they collectively account for a significant proportion of neonatal and childhood morbidity and mortality. Diagnosis is important not only for treatment and prognostication but also for genetic counselling and antenatal diagnosis in subsequent pregnancies.So ,the main problems facing the physician caring for a sick newborn infant are to know when to consider the possibility of a metabolic disorder, what to do to determine quickly and efficiently whether a child has a metabolic disease, and how to treat the patient until a diagnosis is established.
One of the clinical presentations that raises red flags of inborn error of metabolism is persistent or recurrent hypoglycemia. However recognizing hypoglycemia in the newborn may be difficult, because the symptoms of hypoglycemia (i.e., lethargy, poor feeding, hypothermia, and seizures) are non specific. Frequent blood sugar determinations are often required to confirm the suspicion of hypoglycemia. Because inborn errors of metabolism are a relatively infrequent cause of neonatal hypoglycemia, other diagnostic possibilities should be investigated concurrently.
The first possibility to consider is neonatal stress secondary to perinatal asphyxia, hypothermia, or intrauterine malnutrition (e.g., placental abnormalities, prematurity, multiple gestations). The second consideration is the possibility of a hormonal abnormality affecting insulin regulation. The inborn errors of metabolism associated with insulin dysregulation include 3-hydroxacyl-CoA dehydrogenase (HADH ) deficiency and hyperammonemia/hyperinsulinism (HA/HI) syndrome, both of which are diazoxide-responsive.The third possibility to consider is a malformation syndrome, specifically including those syndromes associated with hormonal dysregulation such as Beckwith-Wiedemann syndrome. The fourth possibility is that the patient has a severe hepatocellular or cirrhotic liver disease that leads non specifically to fasting hypoglycemia.
Hypoglycemia may be associated with five categories of inborn errors of metabolism: fatty acid oxidation defects gluconeogenesis defects, glycogen storage diseases, ketogenesis defects, and organic acidemias . The diagnostic approach to hypoglycemia, therefore, must give consideration to entities belonging to each of these categories. Usually, Krebs cycle defects and mitochondrial disorders do not produce hypoglycemia, but these defects should be considered when other evidence points in their direction.
The diagnostic approach must quickly narrow the field of possible diagnoses so that specific treatment can be instituted. The classic approaches to the differential diagnosis of hypoglycemic disorders in children are the fasting study and specialized challenge tests. These studies are, however, not feasible in newborn infants because of the significant risks and technical difficulties associated with performing such studies and because of the lack of control data derived from normal neonates. Alternatively, efforts to determine the cause of hypoglycemia in the newborn infant should include hormonal and biochemical studies before and after feeding and especially during an acute episode of hypoglycemia. Definitive diagnosis might have to be postponed several months until the child is old enough to tolerate a formal fasting study or specialized in vitro cell studies.
An algorithm for diagnosing the disorders that cause neonatal hypoglycemia can be generated from the results of the following studies: blood electrolytes and pH, plasma and urinary ketones, plasma free fatty acids, blood lactate and pyruvate, blood ammonia, liver function tests, plasma and urinary carnitine and acylcarnitine analysis, and urinary organic acids. A specific diagnosis might not be made by these studies, but they are necessary for providing a provisional diagnosis that can be confirmed by specific enzyme analysis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Age groups
- Child
- Study population
- Any Neonate aged 1 day to 28 days admitted to NICU during one and half year period fulfilling the inclusion criteria.
Key inclusion criteria (4 listed)
- Age: 1day to 28 days .
- Sex : Both genders .
- Full Term infant ≥ 37 completed weeks.
- Persistent hypoglycemia (Blood glucose level ≤ 45 mg/dl/2,5 mmol /L) for more than one reading and not responding to IV fluids and /or oral feeding.
Key exclusion criteria (2 listed)
- Age more than 28 days.
- Newborn with surgical problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pattern of metabolic diseases in neonates with hypoglycemia
Time frame: Baseline
Detection of Pattern of metabolic diseases in neonates with hypoglycemia who admitted to Neonatal Intensive Care Unit NICU at Assiut University Children's Hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Hypoglycemia and Metabolic Disease, 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 4 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 7 Aug 2023. 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?
Pattern of metabolic diseases in neonates with hypoglycemia (time frame: Baseline). 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 7 Aug 2023.