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

NCT02379936 | Completed DMC

• 1 other identifier: HildaNeo test study Vietnam
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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. The Swedish company Calmark Sweden AB is now launching a point-of-care technology for LDH analysis called "Hilda Neo". LDH is analyzed on an easy-to-use consumable test card together with an "App" on an ordinary smartphone (in the planned study, iPhone 4S). The result is presented within minutes and presence of hemolysis will be simultaneously detected on the device. The investigators speculate that the use of such a LDH test could serve as a diagnostic help for health-care staff in Vietnam in making the decision when to send a potentially sick newborn to a higher level neonatal unit (in this case the NICU at NPH, Hanoi)

Conditions

Neonatal; Asphyxia

Keywords

Classification; HIE; Infections; Lactate dehydrogenase; Intensive Care

Outcome Measures

Primary Outcomes (1)

• The number of patients admitted to correct level of care, NICU or level 2 unit, in the two groups the admitting doctor has or has not access to plasma LDH respectively.

  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

  at 96 hours after admission

Secondary Outcomes (1)

• The proportion of admitted infants diagnosed as HIE had an LDH value according to the Hilda Card over cut off 600 U/l.

  30 days after completion of study

Study Arms (2)

The NeoHilda Point of care method

ACTIVE COMPARATOR

Evaluating baby including lactate dehydrogenase Levels measured in umbilical core blood using the fast point of care method called Neo Hilda

Device: The Neo Hilda; Device: iPhone 4S

No Measurement of LDH

SHAM COMPARATOR

Evaluating baby without Lactate dehydrogenase result

Procedure: Traditional evaluation

Interventions

The Neo Hilda DEVICE

This is a procedure that measures Lactate dehydrogenase in a fast and reliable way from only 10 microliter of blood. Using a small point of care card and a Smartphone for analysis. Point of care method

Also known as: Neo Hilda, Calmark Sweden AB

The NeoHilda Point of care method

Traditional evaluation PROCEDURE

Traditional way of evaluation

No Measurement of LDH

iPhone 4S DEVICE

The NeoHilda Point of care method

Eligibility Criteria

• Age: 2 Minutes - 36 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All children admitted to the neonatal ward above 32w of age, considered for blood sampling.

You may not qualify if:

• Parental consent missing
• Gestational age less than 33 weeks postnatal age above 36 hours

Sponsors & Collaborators

• National Children's Hospital, Vietnam: lead
• Calmark Sweden AB: collaborator
• Karolinska Institutet: collaborator

Study Sites (1)

Neonatal unit, National hospital of Pedriatrics

Hanoi, Hanoi, 18/879, Vietnam

Location

Related Publications (4)

• Karlsson M, Dung KT, Thi TL, Borgstrom E, Jonstam K, Kasstrom L, Winbladh B. Lactate dehydrogenase as an indicator of severe illness in neonatal intensive care patients: a longitudinal cohort study. Acta Paediatr. 2012 Dec;101(12):1225-31. doi: 10.1111/apa.12014.

  PMID: 22963670 BACKGROUND

• Karlsson M, Wiberg-Itzel E, Chakkarapani E, Blennow M, Winbladh B, Thoresen M. Lactate dehydrogenase predicts hypoxic ischaemic encephalopathy in newborn infants: a preliminary study. Acta Paediatr. 2010 Aug;99(8):1139-44. doi: 10.1111/j.1651-2227.2010.01802.x. Epub 2010 Mar 19.

  PMID: 20236255 BACKGROUND

• Wiberg-Itzel E, Akerud H, Andolf E, Hellstrom-Westas L, Winbladh B, Wennerholm UB. Association between adverse neonatal outcome and lactate concentration in amniotic fluid. Obstet Gynecol. 2011 Jul;118(1):135-142. doi: 10.1097/AOG.0b013e318220c0d4.

  PMID: 21691171 BACKGROUND

• Thoresen M, Liu X, Jary S, Brown E, Sabir H, Stone J, Cowan F, Karlsson M. Lactate dehydrogenase in hypothermia-treated newborn infants with hypoxic-ischaemic encephalopathy. Acta Paediatr. 2012 Oct;101(10):1038-44. doi: 10.1111/j.1651-2227.2012.02778.x. Epub 2012 Jul 27.

  PMID: 22775455 BACKGROUND

MeSH Terms

Conditions

Asphyxia; Infections

Condition Hierarchy (Ancestors)

Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Khu TK Dung, Ass prof.

  National Hospital of Pediatrics

  PRINCIPAL INVESTIGATOR

• Birger Winbladh, Professor

  Karolinska Institutet

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice director NPH; Assoc Prof., MD, PhD

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: March 5, 2015
• Study Start: August 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: August 1, 2014
• Last Updated: March 5, 2015

Record last verified: 2015-02

Locations

VN (1)