Table 2.
Publication recommendations to report laboratory data of neonates – Supplemental Considerations.
| Supplemental Considerationsa | |
| Categories | Definitions and/or examples |
| Clinical Characteristicsb | |
| Study population description | E.g. postmenstrual age, current weight, growth charts used, small/large for gestational age, multiple pregnancy… |
| Details related to the delivery | E.g. vaginal delivery, caesarean section, primary/secondary/urgent caesarean section, cardiotocogram: fetal distress, APGAR score at 1/5/10 minutes, resuscitation yes/no… |
| Maternal characteristics | The neonatal period varies from 28 days in a term infant to months for a very premature infant; therefore, reporting maternal information for impact on neonatal laboratory values may be dependent on the postnatal age of the infant. E.g. GBS status, medication (ab)use during pregnancy, illegal drug use during pregnancy, folate supplementation, concurrent diagnoses, diagnoses related to pregnancy (e.g. gestational diabetes mellitus), infections during pregnancy, chorio-amnionitis, diet during pregnancy, weight gain and BMI during pregnancy… |
| Prenatal medication/interventions | Specify medication class and name. E.g. corticosteroids for lung maturations, maternal antibiotics, fetal interventions… |
| Postnatal medication | E.g. antibiotics, non-steroidal anti-inflammatory drugs, analgesics, sedatives, surfactant… |
| Standard practices within the neonatal unit | E.g. delayed cord clamping, standard prophylactic medication, standard intravenous fluids and parenteral nutrition, lipid supplementation, standard antibiotic regimens, feeding practices… |
| Relevant diagnoses | E.g. respiratory distress syndrome, pulmonary interstitial emphysema, bronchopulmonary disease, intraventricular hemorrhage, periventricular leukomalacia, seizures, patent ductus arteriosus… |
| Relevant treatment modalities | E.g. therapeutic hypothermia, extracorporeal membrane oxygenation, renal replacement therapy, respiratory support and ventilation type, phototherapy thresholds, use of intensive phototherapy, vitamin supplementation… |
| Bio-analytical Informationc | |
| Sample information | E.g. how the sample was transported, manufacturer of the tube in which the sample was taken, quality of the sample (hemolytic/clotted), hemolysis/lipemic/icteric index… |
| Date | Date when the sample was taken and time between taking the sample and the test being performed |
| Laboratory information | E.g. performance specifications of the laboratory, accreditation of the laboratory (national accreditation status against ISO 15189 standards), external quality assessment… |
| Analysis methods | E.g. batch number of the assay used, calibration methods used, centrifugation details, FDA approved yes/no, traceability of the method used to which international standard, intra- and inter-assay variability, if new methods used; rationale for using them and validation efforts, interferences with methods, are tests repeated if outside of physiological range, was stability tested in the local storage conditions… |
| Analytical performance of the test | E.g. sensitivity, specificity, positive/negative predictive value, lower limit of quantification, accuracy of the test… |
| Data-analytical Informationd | |
| Data collection | E.g. procedures for data verification; how to handle results when out of ‘normal’ range, compliance with predetermined analytical plan… |
| Data access statement | Data available for public access yes/no, if yes; how to access them |
a‘Supplemental considerations’ should be reported when considered relevant for the specific study (in appendices or supplementary materials). It is a set of variables that researchers should reflect upon when reporting laboratory data of neonates, but it is not an exhaustive list.
bClinical characteristics that could impact laboratory data should be considered.
cSpecific bio-analytical information is necessary for comparing, replicating, and applying the data provided in research initiatives and clinical practice.
dData-analytical information is needed to assess the quality of the study and to understand how specific conclusions were derived.