Necrotizing enterocolitis

Virginia Milk Bank Seeks Donors for Hospitalized Babies

Retrieved on: 
Wednesday, March 20, 2024
Breast milk, Jaundice, Retinopathy, Nutrient, Lactation, Disease, Memory, Short bowel syndrome, CHKD, Risk, Necrotizing enterocolitis, Hospital, Milk, American Academy, Infant, Death, NICU, Life, Protein, Kidney disease, Intraparenchymal hemorrhage, Woman, Holiday, Antibody, Oxygen, Premature, Paratriathlon, Charli, ROP, Pediatrics (journal), Pediatrics, Dairy

Knowing that her breast milk was the best nutrition for Charli, Moultrie tried pumping to get her milk supply started.

Key Points: 
  • Knowing that her breast milk was the best nutrition for Charli, Moultrie tried pumping to get her milk supply started.
  • After two weeks of consistently pumping with scant results, Moultrie was grateful to learn that Charli could receive safe, pasteurized human milk through the hospital's donor milk bank.
  • The milk bank also has a legacy program for women who have lost a baby but want to donate their milk to help other infants.
  • “But there are times around the holidays and during the summer when we only have enough milk for hospitalized babies.”
    This means the milk bank is not always able to provide milk to babies who have been discharged from the hospital with a doctor’s prescription for pasteurized donor human milk.

Siolta Therapeutics Raises $12 Million in Series C Financing for Clinical Development

Retrieved on: 
Thursday, March 14, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, Infectious Diseases, Health Technology, Other Health, Disease, Risk, Patient, Necrotizing enterocolitis, Khosla Ventures, Infant, NIH, LBP, Johns Hopkins University, Therapy, Drug development, Symbiosis, Pharmaceutical industry

Siolta Therapeutics, a clinical-stage biotech company, has announced the completion of a $12 million Series C financing round.

Key Points: 
  • Siolta Therapeutics, a clinical-stage biotech company, has announced the completion of a $12 million Series C financing round.
  • The round, co-led by SymBiosis and Khosla Ventures, with participation of all existing investors, reflects enthusiasm for Siolta's approach to developing live microbiome-based therapeutics.
  • This financing is timely as Siolta continues to explore the potential of microbiome-based treatments in the areas of maternal and infant health.
  • Dr. Nikole E. Kimes, CEO and Co-founder of Siolta Therapeutics, commented on the funding: "This Series C financing is a key step for Siolta as we continue to develop STMC-103H in the clinic.

Infinant Health Announces Submission of Orphan Drug Designation Application

Retrieved on: 
Tuesday, April 2, 2024
ODD, Bifidobacterium longum, Health, Disease, Incidence, Partnership, Risk, Necrotizing enterocolitis, Health maintenance organization, Biomarker, Disorder, Milk, Mortality, Bacteria, Infant, Death, United, NEC, Mucus, Marketing, FDA, Food, Pharmaceutical industry

DAVIS, Calif., April 2, 2024 /PRNewswire/ -- Infinant Health, a privately-held company focused on changing the trajectory of human health, one baby at a time, announced it has filed an application with the U.S. Food and Drug Administration (FDA) to receive Orphan Drug Designation (ODD) for its drug candidate INF108 for the prevention of necrotizing enterocolitis in pre-term infants.

Key Points: 
  • DAVIS, Calif., April 2, 2024 /PRNewswire/ -- Infinant Health, a privately-held company focused on changing the trajectory of human health, one baby at a time, announced it has filed an application with the U.S. Food and Drug Administration (FDA) to receive Orphan Drug Designation (ODD) for its drug candidate INF108 for the prevention of necrotizing enterocolitis in pre-term infants.
  • The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics.
  • Orphan Drug Designation would qualify INF108 for certain benefits and incentives, including seven years of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain activities, eligibility for orphan drug grants, and the waiver of certain administrative fees.
  • The receipt of Orphan Drug Designation status does not change the regulatory requirements or process for obtaining marketing approval.

Breastfeeding benefits mothers as much as babies, but public health messaging often only tells half of the story

Retrieved on: 
Thursday, February 8, 2024
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Global and U.S. health authorities agree, however, that human milk provides the optimal nutrition for infants.

Key Points: 
  • Global and U.S. health authorities agree, however, that human milk provides the optimal nutrition for infants.
  • The World Health Organization and the American Academy of Pediatrics recommend exclusive breastfeeding for the first six months of an infant’s life.
  • Human milk can be given to infants directly through breastfeeding or by pumping or expressing human milk into a cup or bottle.
  • We are women’s health scholars with combined professional expertise in maternal obstetrics nursing and public health.

Lesser-known benefits of breastfeeding for infants

  • Second, the protection from SIDS was the same for infants who were exclusively breastfed compared to infants who may have received formula in addition to any breastfeeding.
  • In addition, breastfeeding can significantly protect premature infants – those born before 37 weeks of pregnancy – from developing a condition called necrotizing enterocolitis, an inflammation of the intestines that can be fatal.
  • While this condition is rare in full-term infants, it occurs in 5% to 15% of preterm infants.

Benefits for mom, too

  • Breastfeeding also provides important benefits for the mother, such as reducing risks of diabetes and breast and ovarian cancers.
  • These cancers cannot be treated with hormonal therapy and often grow faster than the more commonly diagnosed hormone receptor-positive breast cancers.
  • A 2021 study also found that the longer a woman breastfed, the lower her risk for postpartum depression.

Closing racial gaps

  • Despite the benefits of breastfeeding to both infants and mothers, few U.S. families are able to sustain breastfeeding over time.
  • Black infant-mother pairs not only have the lowest breastfeeding rates in South Carolina, but they also have the lowest rates nationally, compared to other U.S. racial and ethnic groups.
  • Black infants are also more likely to die from SIDS and to be born prematurely.
  • The Southeast U.S. is where the widest racial gaps in breastfeeding exist.

Removing barriers to breastfeeding

  • Reducing barriers is critical to closing racial and geographic gaps in breastfeeding and allowing U.S. mothers and their infants the opportunity to benefit from the life-saving qualities of human milk.
  • Studies show that addressing work-related barriers by making investments in paid family leave, for example, could increase exclusive breastfeeding rates by 15%.
  • Workplaces that support breastfeeding breaks and provide safe and clean spaces for expressing and storing human milk are also important in promoting breastfeeding.
  • Societal investments in breastfeeding-friendly workplace policies will not only yield cost savings and extend breastfeeding rates, but they will shift the burden of breastfeeding from simply being an individual choice to being a public health priority.


Tisha Felder receives funding from the Patient Centered Research Outcomes Institute (PCORI) and National Institutes of Health (NIH). Joynelle Jackson receives funding from Patient Centered Research Outcomes Institute (PCORI).

Real-World Data on Human Milk-Based Fortification Reveals Limitations of Protocol Designs of Two RCTs

Retrieved on: 
Tuesday, February 6, 2024
Growth, Mortality, Bronchopulmonary dysplasia, Hospice and palliative medicine, NEC, Standard of care, BPD, NICU, Disease, Patient, Incidence, Sepsis, RCT, Clinical study design, Isabella Tree, BMBF, Risk, Exclusive, Vulnerable, FAAP, Birth weight, Standard, Necrotizing enterocolitis, Gestational age, Hospital, Dietary supplement

DUARTE, Calif., Feb. 6, 2024 /PRNewswire/ -- Optimizing nutrition for premature infants remains an important focus in neonatal care. More than 20 peer-reviewed studies of 5,000+ preterm infants demonstrated that, compared to bovine milk-based fortifiers (BMBF), Prolacta Bioscience's human milk-based fortifiers (HMBF) improve growth and development1-7 and provide clinically significant reductions in comorbidities.1,2,8-20 The health benefits from the use of HMBF have also shown significant annual cost savings for hospitals.8 More than 100,000 critically ill and preterm infants have received Prolacta's human milk-based nutritional products.21

Key Points: 
  • While the RCTs were intended to provide a head-to-head comparison between fortifier products, the feeding protocols fundamentally differed.
  • HMBF recommendations for best outcomes regarding the day fortification should begin and the speed at which feeds are advanced were not followed in either study.
  • Given these known risks, randomizing extremely premature infants to day-one fortification with BMBF would unjustly endanger this vulnerable patient population.
  • Extensive real-world data affirm EHMD adoption enables critical health improvements for premature infants and major cost reductions for hospitals.

Prolacta's Human Milk-Based Nutrition Has Touched the Lives of 100,000 Premature and Critically Ill Infants Globally

Retrieved on: 
Friday, November 17, 2023
Hospice and palliative medicine, Necrotizing enterocolitis, Disease, Premature, NICU, Pediatrics, Medical Center, BPD, Prenatal care, Neonatology, Mortality, ROP, Monica E. Peek, Place of birth, Retinopathy, Division, Health, Bronchopulmonary dysplasia, Exclusive, MD, Mother, Death, Extrapyramidal system, Hospital, Singing, NEC, Dietary supplement, Nursing, Birth control

DUARTE, Calif., Nov. 17, 2023 /PRNewswire/ -- Prolacta Bioscience, the world's leading hospital provider of 100% human milk-based nutritional products for critically ill, premature infants, proudly commemorates Prematurity Awareness Month 2023 by announcing a significant milestone: more than 100,000 preterm and critically ill infants' lives have been touched by Prolacta's Exclusive Human Milk Diet (EHMD) in hospitals worldwide.1

Key Points: 
  • "We're proud that for more than two decades, Prolacta's 100% human milk-based nutritional products have supported hospitals on the forefront of progressive care to help so many fragile infants in need."
  • The Peeks advocated for Leah Michelle to be on an EHMD and asked the hospital to fortify Brandi's breast milk with a Prolacta fortifier.
  • All types of hospitals have seen the benefits of an EHMD to treat the critically ill, premature infants in their care, including those supporting underserved populations.
  • One example is Los Angeles General Medical Center (formerly LAC+USC Medical Center), among the largest public hospitals in the U.S.

Astarte Medical and Tiny Health Join Forces to Optimize Gut Health for Vulnerable Preterm Infants

Retrieved on: 
Thursday, September 21, 2023
Partnership, Asthma, Obesity, Newcastle University, NICU, Gestational age, Parent, Dermatitis, Late preterm infant, Survival, Nutrient, Necrotizing enterocolitis, Fungus, Mother, Data, Risk, Immune system, Parasitism, Growth, ICU, Bacteria, Probiotic, Virus, Birth control, Dietary supplement

YARDLEY, Pa. and AUSTIN, Texas, Sept. 21, 2023 /PRNewswire-PRWeb/ -- Astarte Medical, a leading pediatric clinical intelligence company, is forming a joint venture with Tiny Health, makers of gut microbiome tests for babies and expecting parents. The partners have agreed to develop a clinical-facing technology solution to support gut health for preterm and critically ill infants receiving care in the neonatal ICU.

Key Points: 
  • The partners have agreed to develop a clinical-facing technology solution to support gut health for preterm and critically ill infants receiving care in the neonatal ICU.
  • "By partnering with Astarte Medical, we're extending our solution to support infants and families at their most vulnerable time.
  • In a previous multi-center microbiome study, Astarte Medical identified six gut community types among nearly 300 preterm infants born under 34 weeks gestational age.
  • Tiny Health will offer NICU parents the option to test their infants post-discharge to extend the understanding of the maturity patterns of infants born preterm.

Sentynl Therapeutics Announces Presentation of Study Evaluating the Efficacy and Safety of NULIBRY® (fosdenopterin) for the Treatment of MoCD Type A at 2023 SSIEM Annual Symposium

Retrieved on: 
Thursday, September 7, 2023
Seizure, Consultant, Infection, European Medicines Agency, Encephalopathy, Survival, Necrotizing enterocolitis, Genetic distance, Cox, Whole genome sequencing, Biochemistry, Molecular medicine, Ministry, Fosdenopterin, RSV, Patient, University of Cologne, Risk, Chemistry, Growth, Mortality, Saint Mary's Hospital, Hospital, Rare, Caregiver, Therapy, Death, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Molybdenum cofactor deficiency, Pneumonia, Food, Safety, Pharmaceutical industry, Metabolism, Health

SOLANA BEACH, Calif., Sept. 7, 2023 /PRNewswire/ -- Sentynl Therapeutics, Inc. (Sentynl), a U.S.-based biopharmaceutical company focused on bringing innovative therapies to patients living with rare diseases, announced that data evaluating NULIBRY® (fosdenopterin) for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A were presented at the 2023 Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual Meeting on Aug. 30 in Jerusalem. NULIBRY is indicated to reduce the risk of mortality in patients with MoCD Type A, an ultra-rare, autosomal recessive, inborn error of metabolism causing sulfite-induced neurodegeneration and early death.

Key Points: 
  • NULIBRY is indicated to reduce the risk of mortality in patients with MoCD Type A, an ultra-rare, autosomal recessive, inborn error of metabolism causing sulfite-induced neurodegeneration and early death.
  • "Early treatment with fosdenopterin (NULIBRY) improves survival and neurodevelopmental outcomes, reducing burden on patients and caregivers."
  • Treatment with rcPMP/NULIBRY led to a normalization of MoCD Type A-associated urinary biomarker levels.
  • To further evaluate the safety and efficacy of NULIBRY, a post-approval non-interventional study is being initiated in Europe.

New Study Finds Improved Long-Term Neurodevelopmental Outcomes for Extremely Premature Infants Fed Prolacta's Exclusive Human Milk Diet (EHMD)

Retrieved on: 
Wednesday, November 9, 2022
Food, Health maintenance organization, Hospital, Late preterm infant, Texas Children's Hospital, Lactoferrin, Flavored fortified wine, Growth, FAAP, FDA, Part, Department, NICU, Article, FDA Food Safety Modernization Act, Birth weight, Brain, Mixed, Baylor College of Medicine, NEC, Antibody, Life, Journal, CMD, Method, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Science, Age, Health, Bayley Scales of Infant Development, Nutritional science, Child, Immunity, Jean-Louis Vincent, Journal of Perinatology, Necrotizing enterocolitis, ELBW, Pasteurization, Safety, Trial of the century, Milk, UHT, Birth control, MD, Maternal–fetal medicine, Facebook, Neonatology

DUARTE, Calif., Nov. 9, 2022 /PRNewswire/ -- Prolacta Bioscience®, the world's leading hospital provider of 100% human milk-based nutritional products for critically ill, premature infants, announced today the publication of a journal article that showed improved long-term neurodevelopmental outcomes in extremely premature infants who received Prolacta's 100% human milk-based fortifiers as part of an Exclusive Human Milk Diet (Prolacta's EHMD), compared with infants fed a cow milk-based diet in the neonatal intensive care unit (NICU).1 

Key Points: 
  • Researchers assessed the infants' development using the Bayley Scales of Infant Development III (BSID-III), the standard measure of infants' neurological development.
  • Hair, MD, of the Section of Neonatology, Department of Pediatrics, Baylor College of Medicine, Texas Children's Hospital, Houston, Texas.
  • "This data is further evidence that human milk nutrition and fortification are both imperative for long-term brain development in infants born prematurely."
  • The major difference between cow milk-based and human milk-based nutritional products is the composition notably, the bioactive components that are unique to human milk.

Thousands of Parents Filing Lawsuits Against Baby Formula Manufacturers

Retrieved on: 
Wednesday, September 21, 2022
Enfamil, NEC, Pregnancy, Parent, Degenerative disease, Milk, Similac, Fed, Diagnosis, Necrotizing enterocolitis

KILLEEN, Texas, Sept. 21, 2022 /PRNewswire/ -- Formula manufacturers have come under fire for failing to properly label and warn parents about a serious gastrointestinal condition called necrotizing enterocolitis (NEC) that results when premature infants ingest cow's milk-based products.

Key Points: 
  • KILLEEN, Texas, Sept. 21, 2022 /PRNewswire/ -- Formula manufacturers have come under fire for failing to properly label and warn parents about a serious gastrointestinal condition called necrotizing enterocolitis (NEC) that results when premature infants ingest cow's milk-based products.
  • These Baby Formula Lawsuits stem from manufacturers like Enfamil and Similac creating and marketing high-calorie formulas from cow's milk especially for premature babies without warning of the danger.
  • Babies born before the 37th week of pregnancy are 4.2 times more likely to develop NEC when given cow's milk baby formula.
  • The Carlson Law Firm is representing families who 1) had a baby born before the 37th week of gestation and 2) the baby was fed formula or fortifier by Similac or Enfamil before an NEC diagnosis.