Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 5, 2019
Date Accepted: May 6, 2020
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Premature or small for gestational age? International multicenter trial protocol for classification of the low birth weight newborn through the optical properties of the skin
ABSTRACT
Background:
A low birth weight is an independent risk factor for adverse infant outcomes and a predictor of chronic disease in adulthood. In these situations, differentiating between prematurity and small for gestational age (SGA) or simultaneous conditions are essential to ensuring adequate care. Such diagnoses, however, depend on reliable pregnancy dating, which can be challenging in developing countries. A new medical optoelectronic device was developed to estimate gestational age (GA) at birth based on newborn skin reflection.
Objective:
This study will aim to evaluate the device’s ability to detect premature, SGA, or both disorders as well as predict short-term pulmonary complications in a cohort of low-birth-weight newborns.
Methods:
This protocol was designed for a multicenter cohort study gathering universities hospitals in Brazil and Mozambique. Newborns weighing 500–2500 g will be eligible for inclusion with the best GA available considering the limited resources of low-income countries. Comparator-GA is based on qualified last menstrual period dating or ultrasound assessment before 24 weeks’ gestation. Estimated GA at birth (Test-GA) will be estimated by applying a novel optoelectronic device to the newborn’s foot. The average difference between Test- and Comparator-GA will be analyzed, as will the percentage of newborns who are correctly diagnosed as preterm or SGA. Additionally, in a nested case–control study, the accuracy of skin reflection in the prediction of prematurity-related respiratory problems will be evaluated. The estimated required sample size is 298 newborns.
Results:
Teams of health professionals were trained, and standard operating procedures were developed following the good practice guidelines for the clinical investigation of medical devices for human subjects. The first recruitment started in March 2019 in Brazil. Data collection is planned to end in May 2020, and the results should be available in August 2020.
Conclusions:
The results of this clinical study have the potential to validate a new device to easily assess postnatal GA, supporting SGA identification when pregnancy dating is unreliable or unknown. Clinical Trial: ClinicalTrials.gov registration identifier RBR33rnjf
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