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. 2020 Jul 14;9(7):e16477.
doi: 10.2196/16477.

Premature or Small for Gestational Age Discrimination: International Multicenter Trial Protocol for Classification of the Low-Birth-Weight Newborn Through the Optical Properties of the Skin

Zilma Reis #  1 , Gabriela Vitral #  1 , Rodney Guimarães #  1 , Juliano Gaspar #  1 , Enrico Colosimo  2 , Sergio Taunde  3 , Nilza Mussagy #  3 , Rita Rosado Santos #  4 , Diogo Ayres-De-Campos  4 , Roberta Romanelli #  1
Affiliations

Premature or Small for Gestational Age Discrimination: International Multicenter Trial Protocol for Classification of the Low-Birth-Weight Newborn Through the Optical Properties of the Skin

Zilma Reis et al. JMIR Res Protoc. .

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 is 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 prematurity or SGA, or both conditions simultaneously as well as predict short-term pulmonary complications in a cohort of low-birth-weight newborns.

Methods: This study protocol was designed for a multicenter cohort including referral 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 reliable last menstrual period dating or ultrasound assessment before 24 weeks' gestation. Estimated GA at birth (Test-GA) will be calculated by applying a novel optoelectronic device to the newborn's skin over the sole. The average difference between Test-GA and Comparator-GA will be analyzed, as will the percentage of newborns who are correctly diagnosed as preterm or SGA. In addition, 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 participants. The first recruitment started in March 2019 in Brazil. Data collection is planned to end in December 2020, and the results should be available in March 2021.

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.

Trial registration: ReBec: RBR-33rnjf; http://www.ensaiosclinicos.gov.br/rg/RBR-33rnjf/.

International registered report identifier (irrid): DERR1-10.2196/16477.

Keywords: childbirth; equipment and supplies; fetal growth restriction; photomedicine; prematurity; skin physiological phenomena.

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Conflict of interest statement

Conflicts of Interest: Authors declare a patent deposit on behalf of the Universidade Federal de Minas Gerais and Fundação de Amparo a Pesquisa de Minas Gerais, Brazil, http://www.fapemig.br/en/. The inventors were ZR and RG: BR1020170235688 (CTIT-PN862).

Figures

Figure 1
Figure 1
The development timeline of the preemie-test device. GA: gestational age.
See this image and copyright information in PMC

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