Hypoglycemia in Newborn InfantsNCT03448965
Hypoglycemic and Hyperglycemic Disorders
An observational study of Hypoglycemia in Newborn Infants and Hyperglycemia, run by Assiut University.
Trial summary
Definition of low birth weight: Low birth weight infants are those born weighing less than 2500 g. These are further subdivided into: Very Low Birth Weight : Birth weight <1,500 g Extremely Low Birth Weight : Birth weight <1,000 g Their survival is directly related to birth weight, with approximately 20% of those… Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Hypoglycemia in Newborn Infants, Hyperglycemia
- What is being tested?
- random blood sugar
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2018to 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 28 days
- All sexes
- No healthy volunteers
- Child
Study population: all low birth weight babies
Who may be able to join
- All neonates admitted to neonatology unit
- From 0-28 days
- Weighting less than 2500gm
Who cannot join
- Any neonate weighting more than 2500 gm
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Glycemic Disorders in Low Birth Weight Babies
Definition of low birth weight:
Low birth weight infants are those born weighing less than 2500 g. These are further subdivided into:
- Very Low Birth Weight : Birth weight <1,500 g
- Extremely Low Birth Weight : Birth weight <1,000 g Their survival is directly related to birth weight, with approximately 20% of those between 500 and 600 g and>90% of those between 1,250 and 1,500 g surviving. Perinatalcare has improved the rate of survival of low birth weight infants.
Read the detailed description
Causes of low birth weight:
- Premature birth
- Intrauterine growth restriction, which are most often Due to different placental problems and health problems of the mother or new-born
RISK FACTORS:
- Age: Teen mothers have a much higher risk of having VLBW infant.
- Multiple birth babies are at increased risk of being VLBW because they often are premature. More than 50% of twins and other multiple gestations are VLBW if <15 years
- Maternal health: Women exposed to drugs, alcohol, and cigarettes during pregnancy are more likely to have low birth weight babies. Mothers of lower socioeconomic
- Race: African-American babies are twice as likely as Caucasian to be very low birth weight
- Conditions
- Hypoglycemia in Newborn Infants, Hyperglycemia
- Being tested
- random blood sugar
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
random blood sugarDiagnostic test
do random blood sugar at 0 hour - 2 hours- 4 hours and after 6 hours
What is being measured
The primary outcome is the main question the study is designed to answer.
glycemic disorders in low birth weight
to detect the prevelance of hypoglycemia and hyperglycemia in low birth weight babies by random blood sugar test
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start15 Dec 2018 (estimated)
- Primary completion20 Oct 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hypoglycemia in Newborn InfantsStudies 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, martinamamdouh fahem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448965
- Sponsor's protocol ID
- NGD
- Status last verified
- Feb 2018
- First submitted
- 22 Feb 2018
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abdulkadir I, Hassan L, Abdullahi F, Sobowale AM, Akeredolu FD, Purdue S, Okpe M, Adewumi OA, Abdullahi U, Onadiran MA, Ogala WN. Outcome of Extremely Low Birth Weight Babies in Zaria; A Ten-Year Review. West Afr J Med. 2015 Jan-Mar;34(1):50-4.
PubMed 26902817Hays SP, Smith EO, Sunehag AL. Hyperglycemia is a risk factor for early death and morbidity in extremely low birth-weight infants. Pediatrics. 2006 Nov;118(5):1811-8. doi: 10.1542/peds.2006-0628.
PubMed 17079549Rozance PJ, Hay WW Jr. New approaches to management of neonatal hypoglycemia. Matern Health Neonatol Perinatol. 2016 May 10;2:3. doi: 10.1186/s40748-016-0031-z. eCollection 2016.
PubMed 27168942Eichenwald EC, Stark AR. Management and outcomes of very low birth weight. N Engl J Med. 2008 Apr 17;358(16):1700-11. doi: 10.1056/NEJMra0707601. No abstract available.
PubMed 18420502
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Disorders in Low Birth Weight Babies
- ClinicalTrials.gov ID
- NCT03448965
- Acronym / sponsor ID
- NGD
- Conditions
- Hypoglycemia in Newborn Infants, Hyperglycemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Dec 2018 (estimated)
- Primary completion
- 20 Oct 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 28 Feb 2018 (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.
Definition of low birth weight:
Low birth weight infants are those born weighing less than 2500 g. These are further subdivided into:
- Very Low Birth Weight : Birth weight <1,500 g
- Extremely Low Birth Weight : Birth weight <1,000 g Their survival is directly related to birth weight, with approximately 20% of those between 500 and 600 g and>90% of those between 1,250 and 1,500 g surviving. Perinatalcare has improved the rate of survival of low birth weight infants.
Detailed description
Causes of low birth weight:
- Premature birth
- Intrauterine growth restriction, which are most often Due to different placental problems and health problems of the mother or new-born
RISK FACTORS:
- Age: Teen mothers have a much higher risk of having VLBW infant.
- Multiple birth babies are at increased risk of being VLBW because they often are premature. More than 50% of twins and other multiple gestations are VLBW if <15 years
- Maternal health: Women exposed to drugs, alcohol, and cigarettes during pregnancy are more likely to have low birth weight babies. Mothers of lower socioeconomic
- Race: African-American babies are twice as likely as Caucasian to be very low birth weight
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- all low birth weight babies
Key inclusion criteria (3 listed)
- All neonates admitted to neonatology unit
Key exclusion criteria (1 listed)
- Any neonate weighting more than 2500 gm
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 |
|---|---|---|
| random blood sugardo random blood sugar at 0 hour - 2 hours- 4 hours and after 6 hours | Diagnostic test | – |
Primary outcome
glycemic disorders in low birth weight
Time frame: one year
to detect the prevelance of hypoglycemia and hyperglycemia in low birth weight babies by random blood sugar test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Background: PubMed 26902817Abdulkadir I, Hassan L, Abdullahi F, Sobowale AM, Akeredolu FD, Purdue S, Okpe M, Adewumi OA, Abdullahi U, Onadiran MA, Ogala WN. Outcome of Extremely Low Birth Weight Babies in Zaria; A Ten-Year Review. West Afr J Med. 2015 Jan-Mar;34(1):50-4.
- Background: PubMed 17079549Hays SP, Smith EO, Sunehag AL. Hyperglycemia is a risk factor for early death and morbidity in extremely low birth-weight infants. Pediatrics. 2006 Nov;118(5):1811-8. doi: 10.1542/peds.2006-0628.
- Background: PubMed 27168942Rozance PJ, Hay WW Jr. New approaches to management of neonatal hypoglycemia. Matern Health Neonatol Perinatol. 2016 May 10;2:3. doi: 10.1186/s40748-016-0031-z. eCollection 2016.
- Background: PubMed 18420502Eichenwald EC, Stark AR. Management and outcomes of very low birth weight. N Engl J Med. 2008 Apr 17;358(16):1700-11. doi: 10.1056/NEJMra0707601. No abstract available.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoglycemia in Newborn Infants and Hyperglycemia, 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 3 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: status not confirmed, as of the sponsor's last update on 28 Feb 2018. 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?
Contact samia atwa, prof (01223971326, Samia26@aun..edu.egs), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glycemic disorders in low birth weight (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03448965, which also lists 4 linked publications.
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 28 Feb 2018.