39 Participants Needed

High-Calorie Formula for Neonatal Abstinence Syndrome

LP
Overseen ByLisa Palmieri, BA
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Yale University
Must be taking: Methadone
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

A randomized clinical study in NAS infants managed via the Eat, Sleep, Console (ESC) approach comparing early weight loss on a standard-caloric density versus high-caloric density feeding regimen.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is high-calorie formula safe for infants?

Research suggests that high-energy infant formulas are generally safe for infants, with studies showing they can be used without major side effects. However, more data is needed to fully understand their long-term safety and effects on growth and metabolism.12345

How is the high-calorie formula treatment different for neonatal abstinence syndrome?

The high-calorie formula is unique because it provides more energy per volume compared to standard formulas, which may help infants with neonatal abstinence syndrome (NAS) who have increased energy needs. This approach is different from other treatments that focus on reducing symptoms or using medications, as it aims to support growth and energy intake directly through nutrition.12567

What data supports the effectiveness of the treatment High-calorie formula for Neonatal Abstinence Syndrome?

Research shows that high-energy formulas can help infants with growth issues gain weight effectively, as seen in cases of growth faltering and critical illnesses. These formulas provide extra calories and nutrients, which can be beneficial for infants needing additional nutrition, like those with Neonatal Abstinence Syndrome.128910

Who Is on the Research Team?

MG

Matthew Grossman, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for NAS infants born to mothers aged 18-45 who used methadone during pregnancy. The babies must be at least 36 weeks gestational, over 2200 grams, and not placed for adoption. They should be delivered at Yale New Haven Hospital with plans to attend follow-up visits.

Inclusion Criteria

Delivered at: Yale New Haven Hospital
Confirm that mothers are planning to deliver their infant(s) at Yale New Haven Hospital
My baby was born at or after 36 weeks of pregnancy.
See 8 more

Exclusion Criteria

My infant was in the NICU for more than a day for reasons other than NAS treatment within their first 3 days.
Newborns with serious birth defects.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Infants are randomly assigned to either high-calorie or standard-calorie formula for 14 days

2 weeks
Daily weight measurements

Follow-up

Participants are monitored for weight gain and return to birthweight after treatment

2 weeks
Daily weight measurements at home

Extended Follow-up

Participants are monitored for days to return to birthweight and overall weight change

1 month

What Are the Treatments Tested in This Trial?

Interventions

  • High-calorie formula
Trial Overview The study tests if a high-calorie formula can help NAS infants gain weight better than standard formula. Infants are randomly assigned to one of the two feeding regimens while being managed via the Eat, Sleep, Console approach.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: High-calorie formulaExperimental Treatment1 Intervention
Group II: Standard calorie formulaActive Control1 Intervention

High-calorie formula is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as High-calorie formula for:
🇪🇺
Approved in European Union as High-calorie formula for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Published Research Related to This Trial

A study involving 30 infants with faltering growth showed that a high-energy infant formula (1 kcal/mL) can be safely administered at full strength from day 1, with no significant differences in growth or vomiting between full strength and stepwise introduction groups.
Younger infants (under 12 weeks) experienced more frequent bowel actions when given the formula at full strength, suggesting that a gradual introduction may be beneficial for this age group to minimize gastrointestinal discomfort.
Should high-energy infant formula be given at full strength from its first day of usage?Evans, S., Twaissi, H., Daly, A., et al.[2008]
Infants who received a high-energy formula (HF) after cardiac surgery experienced less weight loss compared to those on a standard formula, indicating that HF may support better weight maintenance in this vulnerable population.
While the HF group had some gastrointestinal intolerance symptoms, such as abdominal distension and gastric retention, these issues were manageable with medication and did not hinder the overall feeding process.
High-energy nutrition in paediatric cardiac critical care patients: a randomized controlled trial.Zhang, H., Gu, Y., Mi, Y., et al.[2020]
Infants hospitalized for critical illnesses are at high risk of undernutrition, which can lead to growth faltering, making appropriate nutritional management crucial.
The use of energy- and nutrient-dense formula (ENDF) in two infants with severe upper airway obstruction resulted in satisfactory weight gain and facilitated catch-up growth, demonstrating its effectiveness without notable adverse effects.
Case Report: Energy- and Nutrient-Dense Formula for Growth Faltering: A Report of Two Cases From India.Kareem, ZU., Panuganti, SK., Bhatia, S.[2021]

Citations

Should high-energy infant formula be given at full strength from its first day of usage? [2008]
High-energy nutrition in paediatric cardiac critical care patients: a randomized controlled trial. [2020]
Case Report: Energy- and Nutrient-Dense Formula for Growth Faltering: A Report of Two Cases From India. [2021]
Randomized comparison of a nutrient-dense formula with an energy-supplemented formula for infants with faltering growth. [2008]
Human milk fortification and use of infant formulas to support growth in the neonatal intensive care unit. [2023]
Should Partial Hydrolysates Be Used as Starter Infant Formula? A Working Group Consensus. [2022]
Hydrolyzed Formula With Reduced Protein Content Supports Adequate Growth: A Randomized Controlled Noninferiority Trial. [2019]
[Clinical effect of extensively hydrolyzed formula in preterm infants: an analysis of 327 cases]. [2020]
Effect of Low Lactose Formula on the Short-Term Outcomes of Neonatal Abstinence Syndrome: A Systematic Review. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Effects of Partially Hydrolyzed Formula on Severity and Outcomes of Neonatal Abstinence Syndrome. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security