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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ERAS releases its guidelines for Antenatal and Peri-operative care in Cesarean Delivery

The Enhanced Recovery After Surgery (ERAS®) Society recently released its evidence-based, based practice recommendations to accelerate recovery after cesarean delivery (CD).

The recommendations published online ahead of print in the American Journal of Obstetrics and Gynecology involve interventions that start 30-60 minutes before skin incision and extends till the patient is discharged from hospital spanning the pre-operative, intra-operative, and post-operative phases of the CD.

The ERAS protocols were first introduced 15 years ago by Wilmore and Kehlet for colorectal surgery and are now successfully applied in other surgical disciplines like breast, urological, pancreatectomy, liver resection, and gynecologic surgery.

The ERAS team used Embase and PubMed to look at studies spanning 51 years (1966-2017) to gather evidence for developing the protocols and recommendations. The team created maternal FOCUSED pathways that involve protocols for the preoperative, intraoperative, and postoperative phase of the CD. GRADE system was used to assess the quality of studies.

The preoperative recommendations start 30-60 minutes before the skin incision for both elective and emergency cesarean sections and include a one on one communication with the patient about oral intake before surgery, what to expect during the surgery, postoperative pain, initiation of lactation, and recovery.  The Antenatal recommendations mainly focus on patient education about nutrition, supplements, delivery, what to expect during a CD and breastfeeding. 

Antenatal and Preoperative recommendations include:

Patient education

Six- to eight-hour fasting for solids and clear oral fluid intake up to two hours before the induction of anesthesia

Use of antacids and histamine H2 receptor antagonists

Hemoglobin optimization

Contact with patient 24 hours before elective CD

Intraoperative recommendations include:

A single dose of broad-spectrum antibiotics before the skin incision

skin preparation with chlorhexidine-alcohol

Fluid balance with 2L crystalloid and prophylactic phenylephrine infusion initiated at 50 mcg/minute

Maintaining perioperative normothermia (forced warm air, warmed IV fluids, room temperature),

Use of neuraxial anesthesia with neuraxial opioids

Prophylaxis against postoperative nausea and vomiting (PONV)

Delayed cord clamping for 30-60 sec

Initializing early skin to skin contact

Preventing PPH by low dose oxytocin infusion

Postoperative recommendations include :

Encouraging early oral intake within 2 hours

Early mobilization

Early removal of urinary catheter

Regular use of multimodal pain reliever

No VTE prophylaxis with heparin

Pneumatic compression stocking for VTE prophylaxis

Consultation with a lactational expert

Complete neonatal evaluation by the neonatal team

Abstract

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ACOG updates recommendations for diagnostic imaging during pregnancy and lactation

http://www.infantrisk.com/content/radiological-procedures-pregnancy

ACOG has issued recommendations addressing the concerns surrounding the use of X-ray, sonography, nuclear medicine, CT and MRI in pregnancy and lactation. The committee opinion was published in October issue of Journal Obstetrics and Gynecology.

These investigative modalities have become an integral part of our diagnostic armamentarium for evaluating acute and chronic conditions. However, there is confusion and fear surrounding these tests among physician and patients alike that many times they are delayed or totally avoided. Many a times breast feeding is stopped while patient undergo these investigations.

The ACOG’s committee on obstetric practice make the following recommendations:

Ultrasonography and MRI are safe and are the imaging modalities of choice in pregnancy and lactation, although they should be availed only when they are expected to answer a relevant clinical dilemma or are provide health benefit to the patient.

Routine radiography, computed tomography (CT) scan, or nuclear medicine imaging techniques exposes the pregnant women to a dose that is much lower than what is associated with fetal harm and so these techniques should be used if deemed necessary in addition to USG or MRI or alone if they answer the relevant clinical question.

The use of gadolinium contrast with MRI is not advised in routine practice and should only be used as contrast if it significantly improve the diagnosis and maternal and fetal outcome during pregnancy.

Breastfeeding need not be interrupted after gadolinium administration.

Nuclear Medicine imaging should be limited to the use of technetium 99m at 5 mGy when indicated during pregnancy. 

Radioactive iodine (iodine 131) readily crosses placenta and is absolutely contraindicated in pregnancy.

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FDA warning against domperidone use by lactating mothers to increase milk production.

The dopamine receptor antagonist domperidone, which may increase milk production in lactating women, is associated with serious cardiac risks, and should not be used for lactation enhancement, according to a commentary published in the June issue of Obstetrics and Gynecology.

Catherine A. Sewell, MD, MPH, from the U.S. Food and Drug Administration in Silver Spring, Maryland, and colleagues published this commentary to discuss the safety issues associated with use of domperidone and to raise the awareness among healthcare providers in US against the use of domperidone as galactagogue.

Although domperidone is approved in several countries outside the U.S. to treat certain gastric disorders, it is not approved in any country, including the U.S., for enhancing breast milk production in lactating women and is also not approved in the U.S. for any indication.

According to a release by FDA “The serious risks associated with domperidone include cardiac arrhythmias, cardiac arrest, and sudden death. These risks are related to the blood level of domperidone, and higher levels in the blood are associated with higher risks of these events.”

The U.S. Food and Drug Administration (FDA) issued an import alert in 2004, updated in 2016, explaining that the importation of domperidone is illegal with limited exceptions, including when imported pursuant to an investigational new drug application.

A public safety warning has already been issued for domperidone, as the drug is sometimes illegally obtained from other countries and used to enhance milk production.

Only scant evidence exists to support its use as lactation enhancer but considerable information exists on domperidone's cardiac risks including QT prolongation, torsades de pointes, and sudden cardiac death, including among lactating women.

“In light of limited efficacy data that do not offset safety concerns from a public health perspective, we continue to caution against using domperidone for lactation enhancement,” the commentary states.

The FDA warning release can be accessed here.