Compare Between the Serum Level of Lcarnitine in HIE Cases and TTNHIELcarnitineNCT04546321
Measuring Serum Level of Total L Carnitine in HIE and TTN
An observational study of Compare Between the Serum Level of Lcarnitine in HIE Cases and TTN, run by Assiut University.
Trial summary
It is a comparative prospective and observational study conducted at Neonatal Intensive Care Unit (NICU) in Assiut University Children Hospital. All cases of perinatal asphyxia and TTN admitted to the NICU during the period 12-2016 to 6-2018 were included. Read more about this study
- Who is it for?
- Ages 1 minute to 30 days
- Conditions the study is for
- Compare Between the Serum Level of Lcarnitine in HIE Cases and TTN
- What is being tested?
- serum L carnitine level measuring
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Jun 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 minute to 30 days
- All sexes
- No healthy volunteers
- Child
Study population: fulllterm newborn admitted to the NICU
Who may be able to join
- all the full-term HIE and TTN cases admitted to NICU of the University Children Hospital during the period of December 2016 to June 2018.
Who cannot join
- The newborns with perinatal asphyxia who died before admission, gestational age<37wks and those with congenital anomalies were excluded
About this study
Official title: Comparative Study Between Serum Level of Total L Carnitine in Neonatal Hypoxic Ischemic Encephalopathy (HIE) and Transient Tachypnea of the Newborn (TTN)
It is a comparative prospective and observational study conducted at Neonatal Intensive Care Unit (NICU) in Assiut University Children Hospital. All cases of perinatal asphyxia and TTN admitted to the NICU during the period 12-2016 to 6-2018 were included. All the included newborns were examined and the serum level of total L carnitine was measured. Then we compared the demographic data and investigation of cases with HIE with the outcome of those cases. Results: It was found that serum level of total L carnitine decreased in both HIE and TTN cases but without significant difference with mean 5.51 ± 1.30 umol/l in group I vs 6.22 ± 2.56 umol/l in group II. The male factor with changes in the serum sodium (132.63 ± 9.30) and abnormal serum creatinine level [1.4 (0.7-15.0)] were significantly related to the outcome of cases with HIE
Read the detailed description
This is a prospective comparative and observational study included all the full-term HIE and TTN cases admitted to NICU of the University Children Hospital during the period of December 2016 to June 2018. The newborns with perinatal asphyxia who died before admission, gestational age<37wks and those with congenital anomalies were excluded. The study included 35 HIE Patients and 12 TTN patients. All cases were subjected to full perinatal history and clinical examination. HIE cases were classified clinically by Sarnat staging (Sarnat and Sarnat, 1976) [10]. HIE cases were subjected to investigations as capillary blood gases, complete blood count (CBC), and electrolytes, renal function. The demographic data and the results of HIE investigations will be correlated to the outcome. The serum level of total L carnitine was measured for both HIE and TTN cases by sending 1 ml of newborn serum frozen to be analyzed by human ELIZA (Enzyme Linked Immunosorbent Assay) kit (SinoGeneClon Biotech Co.,Ltd) within the 1st week of life and compared with each other. Normal range in males and females 17.4-58.7umol/l. the
Statistical analysis:
Data entry and data analysis were done using SPSS version 22 (Statistical Package for Social Science). Data were presented as number, percentage, mean, standard deviation and median. Chi-square and Fisher Exact tests were used to compare between qualitative variables. Independent samples t-test was used to compare quantitative variables between two groups and ANOVA test for more than two groups in case of parametric data. Mann-Whitney test was used to compare quantitative variables between groups in case of non-parametric data. P-value considered statistically significant when P < 0.05.
Results:
The study included 35 cases of HIE (group I) and 12 cases of TTN (group II) all cases were full-term babies there was no significance between the two groups in the demographic data (sex, weight and maternal age) . There were (19) 54.3% females and (16) 47.7% males in the first group versus 33.3% females and 66.7% males in the 2nd group.The mean birth weight for the first group was 2.78 ± 0.50 kg versus 2.86 ± 0.28 kg in the second group. There were 22 cases and 11 cases delivered by cesarean section in the 1st group and the 2nd group respectively. There were 13 cases and 1 case delivered by normal vaginal delivery in group I and group II respectively. On comparison between the two groups in measuring the serum level of total L carnitine. The serum level of total L carnitine had decreased in both groups with a mean of 5.51 ± 1.30 umol/l in group I versus 6.22 ± 2.56 umol/l in group II. Then after correlation between the demographic data and investigations of cases of HIE with the outcome there was a significant correlation between male factor and death by deaths of 66% of males with HIE and also there was a significant correlation between the outcome and grade III of HIE ( 86.7% of grade III died) .There were a significant correlation between hyponatremia (132.63 ± 9.30) with death of HIE cases and abnormal serum creatinine [1.4 (0.7-15.0)] with death of HIE cases.
- Being tested
- serum L carnitine level measuring
- Keywords
- HIE,Lcarnitine level,TTN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum L carnitine level measuringOther
The serum level of total L carnitine was measured for both HIE and TTN cases
| Study group | Role | What they receive |
|---|---|---|
| HIE group (I) | All fullterm newborn admitted to the NICU with Hypoxic Ischemic Encephalopathy during the study period Receives: Other: serum L carnitine level measuring | |
| TTN group(II) | All fullterm babies with Transient Tachypnea of the Newborn admitted to the NICU during the study period Receives: Other: serum L carnitine level measuring |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison
The serum level of total L carnitine was measured for both HIE and TTN cases
Measured: 18 months
Secondary outcomes (1)
correlation
. The demographic data and the results of HIE investigations will be correlated to the outcome
Measured: 7-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study startDec 2016
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compare Between the Serum Level of Lcarnitine in HIE Cases and TTNStudies 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Shalaby, Assiut University
- Investigators
- Amira Shalaby, Principal investigator, NICU,Assiut University Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546321
- Sponsor's protocol ID
- Assiut U CH
- Acronym
- HIELcarnitine
- Status last verified
- Sep 2020
- First submitted
- 5 Sep 2020
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To share the IPD related to the results
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Serum Level of Total L Carnitine in Neonatal Hypoxic Ischemic Encephalopathy (HIE) and Transient Tachypnea of the Newborn (TTN)
- ClinicalTrials.gov ID
- NCT04546321
- Acronym / sponsor ID
- HIELcarnitine / Assiut U CH
- Keywords
- HIE,Lcarnitine level,TTN
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 14 Sep 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.
It is a comparative prospective and observational study conducted at Neonatal Intensive Care Unit (NICU) in Assiut University Children Hospital. All cases of perinatal asphyxia and TTN admitted to the NICU during the period 12-2016 to 6-2018 were included. All the included newborns were examined and the serum level of total L carnitine was measured. Then we compared the demographic data and investigation of cases with HIE with the outcome of those cases. Results: It was found that serum level of total L carnitine decreased in both HIE and TTN cases but without significant difference with mean 5.51 ± 1.30 umol/l in group I vs 6.22 ± 2.56 umol/l in group II. The male factor with changes in the serum sodium (132.63 ± 9.30) and abnormal serum creatinine level [1.4 (0.7-15.0)] were significantly related to the outcome of cases with HIE
Detailed description
This is a prospective comparative and observational study included all the full-term HIE and TTN cases admitted to NICU of the University Children Hospital during the period of December 2016 to June 2018. The newborns with perinatal asphyxia who died before admission, gestational age<37wks and those with congenital anomalies were excluded. The study included 35 HIE Patients and 12 TTN patients. All cases were subjected to full perinatal history and clinical examination. HIE cases were classified clinically by Sarnat staging (Sarnat and Sarnat, 1976) [10]. HIE cases were subjected to investigations as capillary blood gases, complete blood count (CBC), and electrolytes, renal function. The demographic data and the results of HIE investigations will be correlated to the outcome. The serum level of total L carnitine was measured for both HIE and TTN cases by sending 1 ml of newborn serum frozen to be analyzed by human ELIZA (Enzyme Linked Immunosorbent Assay) kit (SinoGeneClon Biotech Co.,Ltd) within the 1st week of life and compared with each other. Normal range in males and females 17.4-58.7umol/l. the
Statistical analysis:
Data entry and data analysis were done using SPSS version 22 (Statistical Package for Social Science). Data were presented as number, percentage, mean, standard deviation and median. Chi-square and Fisher Exact tests were used to compare between qualitative variables. Independent samples t-test was used to compare quantitative variables between two groups and ANOVA test for more than two groups in case of parametric data. Mann-Whitney test was used to compare quantitative variables between groups in case of non-parametric data. P-value considered statistically significant when P < 0.05.
Results:
The study included 35 cases of HIE (group I) and 12 cases of TTN (group II) all cases were full-term babies there was no significance between the two groups in the demographic data (sex, weight and maternal age) . There were (19) 54.3% females and (16) 47.7% males in the first group versus 33.3% females and 66.7% males in the 2nd group.The mean birth weight for the first group was 2.78 ± 0.50 kg versus 2.86 ± 0.28 kg in the second group. There were 22 cases and 11 cases delivered by cesarean section in the 1st group and the 2nd group respectively. There were 13 cases and 1 case delivered by normal vaginal delivery in group I and group II respectively. On comparison between the two groups in measuring the serum level of total L carnitine. The serum level of total L carnitine had decreased in both groups with a mean of 5.51 ± 1.30 umol/l in group I versus 6.22 ± 2.56 umol/l in group II. Then after correlation between the demographic data and investigations of cases of HIE with the outcome there was a significant correlation between male factor and death by deaths of 66% of males with HIE and also there was a significant correlation between the outcome and grade III of HIE ( 86.7% of grade III died) .There were a significant correlation between hyponatremia (132.63 ± 9.30) with death of HIE cases and abnormal serum creatinine [1.4 (0.7-15.0)] with death of HIE cases.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIE group (I) | – | Other: serum L carnitine level measuringAll fullterm newborn admitted to the NICU with Hypoxic Ischemic Encephalopathy during the study period |
| TTN group(II) | – | Other: serum L carnitine level measuringAll fullterm babies with Transient Tachypnea of the Newborn admitted to the NICU during the study period |
Who may qualify
- Ages
- 1 minute to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- fulllterm newborn admitted to the NICU
Key inclusion criteria (1 listed)
- all the full-term HIE and TTN cases admitted to NICU of the University Children Hospital during the period of December 2016 to June 2018.
Key exclusion criteria (1 listed)
- The newborns with perinatal asphyxia who died before admission, gestational age<37wks and those with congenital anomalies were excluded
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 |
|---|---|---|
| serum L carnitine level measuringThe serum level of total L carnitine was measured for both HIE and TTN cases | Other | HIE group (I), TTN group(II) |
Primary outcome
comparison
Time frame: 18 months
The serum level of total L carnitine was measured for both HIE and TTN cases
1 secondary outcome
correlation
Time frame: 7-10 days
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 14 Sep 2020.
- Individual participant dataSharing planned: Yes. To share the IPD related to the results
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.
Amira Shalaby principal investigator
NICU,Assiut University Children Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Compare Between the Serum Level of Lcarnitine in HIE Cases and TTN, 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 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 14 Sep 2020. 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?
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?
comparison (time frame: 18 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 14 Sep 2020.