Measuring Serum Level of Total L Carnitine in HIE and TTN (HIELcarnitine)

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

Study Overview

• Status: Completed
• Conditions: Compare Between the Serum Level of Lcarnitine in HIE Cases and TTN
• Intervention / Treatment: Other: serum L carnitine level measuring

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 Type: Observational
• Enrollment (Actual): 47

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

fulllterm newborn admitted to the NICU

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• The newborns with perinatal asphyxia who died before admission, gestational age<37wks and those with congenital anomalies were excluded

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HIE group (I); All fullterm newborn admitted to the NICU with Hypoxic Ischemic Encephalopathy during the study period	Other: serum L carnitine level measuring; The serum level of total L carnitine was measured for both HIE and TTN cases
TTN group(II); All fullterm babies with Transient Tachypnea of the Newborn admitted to the NICU during the study period	Other: serum L carnitine level measuring; The serum level of total L carnitine was measured for both HIE and TTN cases

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparison	The serum level of total L carnitine was measured for both HIE and TTN cases	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correlation	. The demographic data and the results of HIE investigations will be correlated to the outcome	7-10 days

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Amira Shalaby, NICU,Assiut University Children Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: September 5, 2020
• First Submitted That Met QC Criteria: September 5, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): September 14, 2020
• Last Update Submitted That Met QC Criteria: September 5, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: HIE,Lcarnitine level,TTN
• Other Study ID Numbers: Assiut U CH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: To share the IPD related to the results
• IPD Sharing Time Frame: after publication
• IPD Sharing Supporting Information Type: Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No