Clinical Trial: Evaluation of Lactate Dehydrogenase as Decision Support for Admissions to Neonatal Ward

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of a Point of Care Analyzer for Lactate Dehydrogenase, HildaNeo, as Support for Decisions When Admitting Newborn to the Neonatal Wards at NPH

Brief Summary:

The immediate newborn period is the period of highest morbidity in life. Early signs of serious disease are often vague and difficult to interpret for the non- specialist. Screening lists of clinical signs are useful but have unsatisfactory specificity or sensitivity, cover only one or two diseases, and are complicated to handle in low resource settings.

In critically ill newborns, organ failure to one or multiple organ systems is frequently seen due to inadequate circulation to the tissues. Critical disease will cause hypoxia ischemia of the cells in the affected organs followed by energy deficiency. Independently of the condition causing the energy deficiency this will start a series of events, which initially cause a leaking cell membrane leading to that intracellular components, i.e. the enzyme Lactate dehydrogenase (LDH), will leak out into the blood. Previous research in newborns suggests that LDH is a clinically interesting early predictor of serious illness and may thus serve as an important complement to the clinical examination. If the LDH level is elevated the health care personnel will realize that something is wrong and call for appropriate measures.

Today LDH analysis is performed at the Dept. of Clinical Chemistry with an inexpensive and accurate method. However, this method needs relatively large blood volumes and the delay between blood sampling and results is rather long, often several hours. In addition LDH is sensitive to hemolysis, which is quite common in blood sampling in newborns. When this is detected at the laboratory a new sample will be needed, thus delaying the result even more. Also, smaller health care facilities rarely have the laboratory equipment needed for the analysis of LDH.

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Detailed Summary:

Patients and Methods At admission to NPH, newborn (GA >32 w, ≤36h old) infants referred to NPH with suspect or probable clinical signs of illness for which the physician on call considers that a blood sample is needed will be included in the study when a doctor taking part in the study is present at the ward. When a blood test is indicated, around 2 ml of blood is routinely drawn including an extra 0.1 ml blood for analysis of LDH using the Hilda Neo card.

When an infant fulfils the inclusion criteria the physician on duty will open a downloaded "App" on the provided smartphone and take a photo of the first page of the study protocol including the patients study number time of birth, and the result of the clinical investigation on a simple clinical score protocol. Then the physician presses a "randomise button" on the smartphone to randomise to using the Hilda Neo card or to routine care. If randomised to the Hilda Neo card use the "app" gives instructions how to use the card and guides through the different steps of the test. The result of the LDH test will be presented to the physician immediately at the point-of-care and can be used in the clinical decisions.

To prepare for a following study of the usefulness of LDH when deciding if a baby is ready for transfer from the NICU to ordinary care all included infants will have an LDH test at the routine clinical laboratory daily when other blood samples are drawn. The investigators believe that two LDH tests at 6 - 24 hour intervals are needed for that question. The reason for using two tests with an interval is that a high single LDH value can be expected in a large number of the infants because of the preceding disease while a decreasing value might be a better predictor of an improving status.

The definitions of correct or not correct admission level were:

1. Admitted to NICU care: correct decision=The patient did fulfil the criteria for referral to NICU during the first 80 and 96 hours after admission.
2. Admitted to NICU care: not correct decision=The patient did not fulfil the criteria for referral to NICU during the first 80 to 96 hours after admission.
3. Admitted to level 2 unit: correct decision=The patient did not fulfil the criteria for referral to NICU during the first 80 to 96 hours after admission.
4. Admitted to level 2 unit: not correct decision= The patient did fulfil the criteria for referral to NICU between 80 and 96 hours after admission