FDA clears first ever test to analyze the nutrients in Human Breast Milk

The U.S. Food and Drug Administration recently permitted marketing of a diagnostic test that analyzes nutrients in breast milk. The test will help healthcare providers in managing the specific nutritional needs of newborns and young infants at risk for growth failure due to prematurity or other medical conditions.

Developed and marketed by a Swedish company Miris, the Miris HMA - Human Milk Analyzer reports the fats, carbohydrates, proteins, and energy content of the milk within 60 seconds using 1-3 cc of the milk. 

“For the first time, doctors have access to a test to help analyze the nutrients in breast milk. While this test is not for everyone, it has the potential to aid parents and healthcare providers, mainly in a hospital setting, in better assessing the nutrient needs of certain babies who are not growing as expected,” said Courtney Lias, Ph.D. director of the Division of Chemistry and Toxicology Devices in the FDA’s Center for Devices and Radiological Health in a press release.

“Breast milk provides many health benefits to infants, and for many babies, it can meet their early nutritional needs. But some infants — including those who may be born preterm or have certain health conditions — may need additional nutrients in order to support their optimal growth,” she further added.

“Knowing the macronutrient content of the breast milk may help the health care team and parents make informed decisions on how to fortify the breast milk based on the individual needs of the infant,” explains FDA in the recent press release.

The Miris Human Milk Analyzer can be purchased only through prescription and is for use by trained personnel at clinical laboratories. The device uses approved Infrared transmission spectroscopy to analyze accurately the total solids and energy content contained in the milk along with quantitative measurement of fat, protein and total carbohydrate in a single run.

The device does not use any chemicals and is small, portable and easy to use. The results can be easily transferred to a computer.

The FDA reviewed the Miris Human Milk Analyzer test through the De Novo premarket review pathway and clearance was based on comparable results obtained by analysis of 112 samples of human milk tested by the Miris analyzer and by independent methods. Both methods were equally effective at determining levels of protein, fat, and carbohydrates in the milk.

Certain conditions may limit the ability of the test to accurately determine the milk content like some medications taken by a nursing mother. FDA advises the healthcare provider to use the test results of Miris Human Milk Analyzer along with clinical parameters of the baby in formulating the nutritional plan for the infant and in informed decision making.

FDA has also put in place specific criteria called “special controls” to ensure the accuracy and reliability of the test results and to aid in the nutritional management of certain infants. These “special controls” along with general control helps maintain the specificity and accuracy of this type of tests.

Here is a short overview of how the Miris HMA - Human Milk Analyzer works.

Product page

FDA press release

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Should universal serological screening for Toxoplasmosis be recommended during pregnancy?

Toxoplama gondii is ubiquitous in nature and infects animals and human alike. In immunocompetent host the infection is typically asymptomatic; however, in congenital settings, toxoplasmosis causes a range of manifestations in the fetus and newborn including but not limited to prematurity, IUGR, microcephaly, seizures, myocarditis, and life-long neurological and ophthalmologic sequelae.

The global incidence of congenital toxoplasmosis has been estimated to be 190,100 cases annually which corresponds to a burden of 1.20 million disability-adjusted life years. Yet only a few countries in the world have policies about universal serologic screening during gestation, followed by treatment of women who seroconvert. France is one of such countries where routine serologic screening is performed monthly during pregnancy. 

Surprisingly, In USA, serological screening is not universally recommended, although some obstetric practices do the screening. The current issue of American Journal of Obstetrics and Gynecology reports the results of first RCT Toxogest (ClinicalTrials.gov Identifier: NCT01189448) compare the efficacy and tolerance of pyrimethamine + sulfadiazine(PS) vs spiramycin to reduce placental transmission with an accompanying editorial about the systematic screening of toxoplasmosis during pregnancy.

Since placebo-controlled RCT was not possible, the trial compared the potential of spiramycin vs. PS to treat congenital toxoplasmosis in 150 women who have seroconverted during their second trimester of gestation or later.

Unfortunately, the trial was terminated early because of insufficient participants and problems with funds, but there were fewer transmission and no fetal cerebral toxoplasmosis lesions in the PS group, prompting to perform further research on prevention of congenital toxoplasmosis.

However, there is a lot to learn from results of Toxogest trial write Jose G. Montoya from Department of Medicine, Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, CA in the accompanying editorial.

Based on results of study and literature review so far, the author advises systematic screening for toxoplasmosis in every pregnant woman where Toxoplasma infection is known to occur because of devastating consequences of congenital toxoplasmosis. Further, congenital toxoplasmosis is preventable and treatable in utero.

If a woman tests positive or seroconverts during pregnancy, the question is not about to treat or not to treat, but what to treat with. The author proposed a simple algorithm for serological screening and follow up of pregnant women who were identified to be at risk for seroconversion during gestation (negative for Toxoplasma immunoglobulin G and M).  

If Toxoplasma IgM/IgG remains negative along with normal fetal ultrasound till term, no further treatment is needed. If the patient seroconverts and tests positive for IgM/IgG, follow the following algorithm.

At 18 weeks of pregnancy, do amniotic fluid PCR in patients on Spiramycin or pyrimethamine +sulfadiazine(PS) and follow the algorithm.

Algorithm  after amniotic fluid PCR in Spiramycin group

Algorithm  after amniotic fluid PCR in pyrimethamine +sulfadiazine(PS) group

The author concludes, “It is time to not leave anymore pregnant women who silently seroconvert for toxoplasmosis during gestation in the equivalence of a placebo arm.”

Abstract

Editorial full text

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Vaginal progesterone scores at par with cerclage for preventing preterm births in women with previous mishap and short cervix: a comparison meta-analysis

Vaginal progesterone fares equal with cerclage for preventing preterm births in women who have a short cervix and history of previous mid-trimester miscarriage (MTM) and/or preterm labor (PTL) reports the results of an updated comparison meta-analysis published in July issue of American Journal of Obstetrics and Gynecology.

In a recent update by WHO, every year 15 million babies are born before 37 weeks of gestation and the figures continue to rise. Prematurity is the leading cause of death in children under 5 years of age and is responsible for causing about 1 million deaths worldwide.

In addition, prematurity is a major contributor towards lifelong neurological morbidities such as intellectual disability, cerebral palsy, hearing and visual impairments, and a higher risk of chronic diseases in adulthood.

Women with a previous history of PTL and a short cervix (≤25) face a 3-fold increased risk of recurrent preterm births as compared to women with a cervical length >25 mm in the midtrimester.

The efficacy of vaginal progesterone and cerclage in preventing PTL is a hotly debated topic, but to date, only 2 small RCTs have been conducted to compare these two treatment modalities. However, the sample size was too small to detect any treatment differences.

The 2016 multicenter double-blind randomized placebo-controlled OPPTIMUM trial refuted the claim that progesterone reduces the risk of PTL and helps decrease the associated neonatal morbidity and mortality.

Hence, this adjusted indirect comparison meta-analysis was performed which usually, but not always, provides results similar to head-to-head randomized controlled trials.

An updated literature search of MEDLINE, EMBASE, CINAHL, LILACS, the Cochrane Central Register of Controlled Trials, conference proceedings and research registers of ongoing trials was performed from their inception to March 31, 2018.

All the RCTs comparing vaginal progesterone to placebo/no treatment or cerclage to no cerclage in women with a singleton gestation, previous spontaneous preterm birth, and a sonographic cervical length <25 mm was included in the meta-analysis.

The researchers looked at prevention of preterm birth <35 weeks of gestation and perinatal mortality as the primary outcomes.

Five trials comparing vaginal progesterone vs placebo (265 women), 5 comparing cerclage vs no cerclage (504 women) and the OPPTIMUM study were included in the analysis.

The daily dose of vaginal progesterone used in the trials varied from 90 to 200 mg, and the treatment was administered from 18–25 to 34–36 weeks of gestation. Thirty women in two RCTs underwent a cerclage after randomization.

In direct comparison, the use of vaginal progesterone reduced the risk of preterm birth <35 weeks by 32%, <32 weeks of gestation by 40%, neonatal sepsis by 62%, neonatal morbidity by 71%, and admission to NICU by 54%.

The use of cerclage reduced the risk of preterm birth <35 weeks by 30%, <32 weeks of gestation by 34%, composite neonatal morbidity and mortality by 36%, and birthweight <1500 g by 36%.

Both interventions together were associated with a nonsignificant ∼36% reduction in the rate of perinatal death.

Adjusted indirect comparison meta-analyses didn’t show any differences between vaginal progesterone and cerclage in preventing preterm births and perinatal deaths.

The study has several advantages such as the use of individual patient data, similar patient demographics, and low rates of bias. There were few limitations such as the absence of data on respiratory distress syndrome in the OPPTIMUM study, some women with cerclage received 17-OHPC that could have affected the results and non-reporting of maternal side effects in the individual patient data (IPD) meta-analysis.

In the absence of adequately powered, high-quality, randomized controlled trials comparing vaginal progesterone and cerclage, our indirect comparison treatment meta-analysis provides the best available evidence regarding the comparative efficacy of the 2 interventions.

This meta-analysis results have huge implications in clinical practice. Both progesterone or cerclage show similar efficacy in preventing recurrent preterm births in patients with singleton pregnancy and short cervix. Thus, besides efficacy, the decision to use one intervention over other is based on physician preferences, cost-effectiveness, and maternal side effects.

Full text

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Purdue develops at home wearable preeclampsia testing device

supine pressor test

Researchers at Purdue University are working on an app-based preeclampsia testing that enables pregnant women to use a smartphone to detect her risk of developing preeclampsia.

The team, led by Craig Goergen, an assistant professor in Purdue’s Weldon School of Biomedical Engineering is modifying the way the underused tool called the supine pressor test records the Blood Pressure for a pregnant woman.

“We hope this will allow us to predict and prevent preeclampsia and reduce the number of children born prematurely each year. This could also reduce the long-term health complications for mothers,” Goergen said.

Other team members include George Wodicka, the Dane A. Miller Head of Biomedical Engineering at Purdue, and Kirk Forster, a senior research engineer at the Weldon School.

The supine pressor test measures a woman’s blood pressure in two different positions and the difference predicts her risk of developing the disease. But, to carry out the test, a woman must go visit the hospital or other healthcare providers, not an easy task in some parts of the world.

The researchers are working to combine available existing technologies such as smartphones, a conventional inflatable blood pressure cuff, and a wireless accelerometer (which measures body position) to build an innovative prototype that will detect preeclampsia before it develops.

  

A supine pressor test is an old, valuable tool that assesses blood flow through the kidney, and 90 percent of women with a positive test eventually develop preeclampsia. The women can send the test results to a doctor's office, a health-care system or a centralized network for the results to be read.

Based on the results the women can receive advice about prevention and early management to avoid the development of terminal consequences.

The World Health Organization estimates that nearly 10 percent of all maternal deaths in Africa and Asia are associated with hypertensive disorders during pregnancy and 25 percent of all maternal deaths in Latin America. Most of those deaths are avoidable, according to the WHO.

The American Journal of Obstetrics & Gynecology issued a report last year estimating the costs to the U.S. health-care system for preeclampsia at $2.18 billion for the first 12 months after birth  — $1.03 billion for mothers, and $1.15 billion for babies.

The researchers received a $100,000 Grand Challenges Explorations grant from the Bill & Melinda Gates Foundation in November.

While the Gates Foundation’s goal is to help women in developing countries, Goergen said the device the Purdue researchers are working on also could help women in inner cities and rural areas of the United States and other developed countries.

Here is video by the lead scientist Craig Goergen about the app and wearable device

Purdue News Release

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