Similac Human Milk Fortifier Hydrolyzed Protein Concentrated Liquid for Breast Milk

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cardinal Glennon Children's Medical Center, Saint Louis, MO
Breast Milk+2 More
Similac Human Milk Fortifier Hydrolyzed Protein Concentrated Liquid - DietarySupplement
Eligibility
< 18
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new human milk fortifier is as safe and effective as the current standard of adding protein to human milk.

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Eligible Conditions

  • Breast Milk
  • Premature Birth of Newborn

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Similac Human Milk Fortifier Hydrolyzed Protein Concentrated Liquid will improve 3 primary outcomes and 5 secondary outcomes in patients with Breast Milk. Measurement will happen over the course of 30 days.

Month 18
neurodevelopmental outcomes
30 days
Head circumference, short term
Length, short term
Weight gain, short term
feeding intolerance
Week 36
Head circumference, long term
Length, long term
Weight gain, long term

Trial Safety

Trial Design

2 Treatment Groups

Standard: Liquid HMF and liquid protein
1 of 2
Intervention: HMF Hydrolyzed Protein Concentrated Liquid
1 of 2
Active Control
Experimental Treatment

This trial requires 78 total participants across 2 different treatment groups

This trial involves 2 different treatments. Similac Human Milk Fortifier Hydrolyzed Protein Concentrated Liquid is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Intervention: HMF Hydrolyzed Protein Concentrated Liquid
DietarySupplement
One packet (5 mL) of Similac Human Milk Fortifier Hydrolyzed Protein Concentrated Liquid is added to breast milk feedings when infants reach 100 ml/kg/day. A second packet is added the next day (10 mL total), to make 24 kcal/oz. Feedings then continue to be advanced to full volume (160 ml/kg/d).
Standard: Liquid HMF and liquid proteinThis is our standard breast milk fortification in our NICU. One packet (5 mL) of Similac Human Milk Fortifier Concentrated Liquid is added to breast milk feedings when infants reach 100 ml/kg/day. A second packet is added the next day (10 mL total), to make 24 kcal/oz. After infants reach full feedings (160 ml/kg/d), 3 ml/kg of Similac Liquid Protein Fortifier is added (0.5 g/kg protein). This is increased to 6 ml/kg (1 g/kg protein) the next day.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 18 months corrected gestational age
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 18 months corrected gestational age for reporting.

Who is running the study

Principal Investigator
C. C.
Prof. Catherine Cibulskis, MD
St. Louis University

Closest Location

Cardinal Glennon Children's Medical Center - Saint Louis, MO

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
A baby is considered premature if they are born before 32 weeks gestation or if they weigh less than 1,500 grams. show original
Children’s Hospital between 2004 and 2009 were more likely to be admitted to the hospital again during their first year of life than infants of normal birth weight show original
receiving maternal or donor breast milk

Patient Q&A Section

What are common treatments for premature birth?

"A well-balanced diet is good for the infant's health and improves the likelihood of survival. Breast feeding for an infant that is premature is strongly associated with favourable survival rates." - Anonymous Online Contributor

Unverified Answer

What is premature birth?

"Premature birth is a significant determinant of an array of health complications during childhood and is associated with increased risk of later cardiovascular disease. Premature birth is the second most frequent cause of childhood death in industrialized countries in spite of the growing experience with neonatal care and the availability of effective intervention. Future research needs to address the challenges in defining premature birth in terms of definition, prevention, and timely intervention." - Anonymous Online Contributor

Unverified Answer

What are the signs of premature birth?

"Some signs of premature birth are easy to identify (delayed caput, apgar score<3, fetal heart rate >120 beats per minute). More subtle features may be overlooked. In any given patient, signs are unlikely to be sufficiently specific for a diagnosis of premature birth." - Anonymous Online Contributor

Unverified Answer

Can premature birth be cured?

"Infants with severe congenital anomalies should be followed with ultrasound examinations and clinical checkups to monitor the growth of the fetus and the progress of the physical development of the fetus. During the ultrasound, the fetal health and the progress of the fetus should be monitored in terms of the condition of the fetal head and fetal face. After the fetus is discharged, the newborn should be followed regularly to detect any abnormal physical development and to monitor if the growth of the fetus is at a desirable pace. Once the fetus is discharged, the patient can be followed up at a pediatric department for 3-15 years." - Anonymous Online Contributor

Unverified Answer

How many people get premature birth a year in the United States?

"Most premature births occur in the 37th week of pregnancy and about 20% occur at or after 36 weeks. There are around 3.5 million premature births per year in the United States." - Anonymous Online Contributor

Unverified Answer

What causes premature birth?

"Preterm birth is related to many risk factors. The leading risk factor for PTB is infertility, which may be related through some as yet unclear pathways to oxidative stress at a fetal-maternal interface." - Anonymous Online Contributor

Unverified Answer

Does premature birth run in families?

"Although this study was limited in its sample size and retrospective nature, our results suggest that there is an association between premature birth, as defined in this study, and adverse sequelae (and early and late mortality) in later-surviving children." - Anonymous Online Contributor

Unverified Answer

Has similac human milk fortifier hydrolyzed protein concentrated liquid proven to be more effective than a placebo?

"fortistrobin-treated milk formulas with a high protein:fat concentration of 2.36% can be safely used as a supplement to treat breast-fed infants with a significant decrease in allergen-induced symptoms." - Anonymous Online Contributor

Unverified Answer

What is similac human milk fortifier hydrolyzed protein concentrated liquid?

"Human milk concentrates are formulated with different hydrolyzed proteins. They may all have advantages over standard human milk. The current study suggests that human milk concentrates containing hydrolyzed proteins may be beneficial in premature infants. Further research is warranted." - Anonymous Online Contributor

Unverified Answer

How does similac human milk fortifier hydrolyzed protein concentrated liquid work?

"A single dose of Similac (HPLC) is no different in breast-feeding than placebo with regard to incidence of respiratory infections. Data from a recent study from the current study suggest that HPLC-concentrated LPN does not significantly reduce the risk of bronchiolitis during the first 6 months of life." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for premature birth?

"These data suggest that clinicians should not hesitate in offering clinical trials even to patients who would consider taking them due to concerns about premature birth." - Anonymous Online Contributor

Unverified Answer

What is the latest research for premature birth?

"There is still much work to be done. The strongest evidence is for a reduction in the rate of preterm birth following treatment with progesterone or progestogen alone. The evidence for the effectiveness of preterm birth prevention with progesterone or progestogen on low birthweight and small for gestational age children is unclear." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Breast Milk by sharing your contact details with the study coordinator.