Levetiracetam (All indications)

Neonatal medical care

R analysis
id Study   Lib. in paper Exposition period    Study type  Control type 
 
Tags OR 95%CI x1/n1 x0/n0 no cases no exposed ROB Ref.
S15220
R62421
Bromley (Levetiracetam) (Epilepsy) (Controls exposed to LTG), 2023 Neonatal special care admission during pregnancy (anytime or not specified) prospective cohort exposed to other treatment, sick excluded Adjustment: No 0.55 [0.23;1.34] C
excluded (control group)
8/70   20/106 28 70
ref
S15219
R62408
Bromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023 Neonatal special care admission during pregnancy (anytime or not specified) prospective cohort unexposed, sick Adjustment: No 1.59 [0.52;4.83] C 8/70   6/80 14 70
ref
S12618
R47571
Van Marter (Levetiracetam) (Controls unexposed, disease free), 2021 Need for special care nursery or neonatal intensive care unit (NICU) admission at least 1st trimester prospective cohort unexposed, disease free excluded Adjustment: No 0.87 [0.36;2.09] C
excluded (control group)
10/87   13/100 23 87
ref
S12615
R47553
Van Marter (Levetiracetam) (Controls unexposed, sick), 2021 Need for special care nursery or neonatal intensive care unit (NICU) admission at least 1st trimester excluded prospective cohort unexposed, sick Adjustment: No 0.78 [0.15;4.00] C
excluded (exposition period)
10/87   2/14 12 87
ref
S8986
R30515
Aydin (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2020 Neonatal intensive care unit (NICU) throughout pregnancy retrospective cohort exposed to other treatment, sick excluded Adjustment: No 0.09 [0.00;2.41] C
excluded (control group)
0/10   2/7 2 10
ref
S8987
R30525
Aydin (Levetiracetam) (Controls unexposed, sick), 2020 Neonatal intensive care unit (NICU) throughout pregnancy retrospective cohort unexposed, sick Adjustment: No 0.41 [0.02;9.43] C 0/10   2/22 2 10
ref
S9029
R30783
Bank (Levetiracetam) (Mixed indications), 2017 Admission to neonatal intensive care unit (NICU) or Special Care Nursery during pregnancy (anytime or not specified) prospective cohort exposed to other treatment, sick Adjustment: No 0.83 [0.08;8.24] C 1/7   6/36 7 7
ref
S8983
R30476
Artama (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2013 Admission to neonatal care unit 3rd trimester population based cohort retrospective exposed to other treatment, sick excluded Adjustment: No 1.08 [0.22;5.26] C
excluded (control group)
2/12   24/154 26 12
ref
S8984
R30488
Artama (Levetiracetam) (Controls unexposed, disease free), 2013 Admission to neonatal care unit 3rd trimester population based cohort retrospective unexposed, disease free excluded Adjustment: Yes 2.37 [0.52;10.92]
excluded (control group)
2/12   49,612/689,482 49,614 12
ref
S8985
R30500
Artama (Levetiracetam) (Controls unexposed, sick), 2013 Admission to neonatal care unit 3rd trimester population based cohort retrospective unexposed, sick Adjustment: Yes 1.86 [0.39;8.92] 2/12   152/1,708 154 12
ref
Total 4 studies 1.40 [0.62;3.15] 177 99
x1: number of endpoints among exposed, n1: number of exposed; x0: number of endpoints among non exposed, n0: number of non exposed; C: calculated odds ratio from numbers of events and effectives

Forest plot

StudyTE95% CIn casesn exposedweightROBABCDEF Bromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023Bromley, 2023 1 1.59[0.52; 4.83]147054%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: moderateROB mesure: moderateROB reporting: low Aydin (Levetiracetam) (Controls unexposed, sick), 2020Aydin, 2020 2 0.41[0.02; 9.43]2107%ROB confusion: criticalROB selection: criticalROB classification: moderateROB missing: lowROB mesure: moderateROB reporting: moderate Bank (Levetiracetam) (Mixed indications), 2017Bank, 2017 3 0.83[0.08; 8.24]7713%ROB confusion: criticalROB selection: lowROB classification: lowROB missing: lowROB mesure: moderateROB reporting: moderate Artama (Levetiracetam) (Controls unexposed, sick), 2013Artama, 2013 4 1.86[0.39; 8.92]1541227%ROB confusion: seriousROB selection: lowROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Total (4 studies) I2 = 0% 1.40[0.62; 3.15]177990.25.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Levetiracetam) (Epilepsy) (Controls unexposed, sick; 2: Levetiracetam) (Controls unexposed, sick; 3: Levetiracetam) (Mixed indications; 4: Levetiracetam) (Controls unexposed, sick;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.40[0.62; 3.15]177990%NABromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023 Aydin (Levetiracetam) (Controls unexposed, sick), 2020 Bank (Levetiracetam) (Mixed indications), 2017 Artama (Levetiracetam) (Controls unexposed, sick), 2013 4 case control studiescase control studies 0 Type of controls unexposed, sickunexposed, sick 1.50[0.63; 3.59]170920%NABromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023 Aydin (Levetiracetam) (Controls unexposed, sick), 2020 Artama (Levetiracetam) (Controls unexposed, sick), 2013 3 exposed to other treatment, sickexposed to other treatment, sick 0.83[0.08; 8.24]77 -NABank (Levetiracetam) (Mixed indications), 2017 1 Tags Adjustment   - No  - No 1.26[0.48; 3.25]23870%NABromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023 Aydin (Levetiracetam) (Controls unexposed, sick), 2020 Bank (Levetiracetam) (Mixed indications), 2017 3   - Yes  - Yes 1.86[0.39; 8.90]15412 -NAArtama (Levetiracetam) (Controls unexposed, sick), 2013 1 All studiesAll studies 1.40[0.62; 3.15]177990%NABromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023 Aydin (Levetiracetam) (Controls unexposed, sick), 2020 Bank (Levetiracetam) (Mixed indications), 2017 Artama (Levetiracetam) (Controls unexposed, sick), 2013 40.25.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-3.84.11.9190.000Bromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023Aydin (Levetiracetam) (Controls unexposed, sick), 2020Bank (Levetiracetam) (Mixed indications), 2017Artama (Levetiracetam) (Controls unexposed, sick), 2013

Asymetry test p-value = NaN (by Egger's regression)

not enought points

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded 8983, 8984, 8986, 12618, 15220

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 2.37[0.52; 10.86]49,61412 -NAArtama (Levetiracetam) (Controls unexposed, disease free), 2013 1 unexposed, sick controlsunexposed, sick controls 1.50[0.63; 3.59]170920%NABromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023 Aydin (Levetiracetam) (Controls unexposed, sick), 2020 Artama (Levetiracetam) (Controls unexposed, sick), 2013 3 exposed to other treatment, sick controlsexposed to other treatment, sick controls 0.61[0.30; 1.24]63990%NABromley (Levetiracetam) (Epilepsy) (Controls exposed to LTG), 2023 Aydin (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2020 Bank (Levetiracetam) (Mixed indications), 2017 Artama (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2013 40.510.01.0