Preterm Infant Formula for Premature Birth

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Augusta University

Disqualifiers: Low birth weight, Gastrointestinal disorders, Congenital anomalies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how switching preterm infants from donor human milk to a special preterm infant formula after the first month affects their growth. The researchers aim to determine if this formula improves growth in weight, length, and lean body mass. The study compares two groups: one continues with donor milk, while the other switches to the formula. Infants over 1,250 grams, at least 28 days old, and currently on donor milk (with or without their mother's milk) may be suitable candidates. As an unphased trial, this study provides a unique opportunity to enhance understanding of optimal nutritional practices for preterm infants.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that preterm infant formula is safe for preterm infants?

Research has shown that improvements in caring for premature babies, including special formulas, have helped lower death rates in very small babies. Specifically, these rates have decreased from 9.6% to 6.2%. This suggests that these special formulas are generally safe for babies.

However, concerns exist about using formula. Some studies suggest potential risks, such as a serious gut problem called necrotizing enterocolitis (NEC). Most of this information comes from non-human studies, so clear evidence about these risks in people is lacking.

Overall, special formulas for premature babies have been used for many years and have improved their growth and survival. Participants should consider these points and discuss any concerns with their healthcare providers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for premature infants, which often includes donor milk, Preterm Infant Formula is specially designed to meet the unique nutritional needs of preterm babies. Researchers are excited about this formula because it may provide more consistent nutrient delivery tailored to promote rapid growth and development in these vulnerable infants. Additionally, Preterm Infant Formula could offer a more readily available and standardized option compared to donor milk, which can be limited in supply and variable in composition.

What evidence suggests that preterm infant formula might be an effective treatment for preterm infants?

Research has shown that preterm infant formula, which participants in this trial may receive, can help premature babies grow better in weight and length compared to donor human milk, another treatment option in this trial. Studies have found that babies fed with formula often gain more weight and grow longer than those who receive donated breast milk. This growth at an early stage can significantly impact overall health and development. Some research also suggests that formula may help babies grow taller. While donor milk offers benefits, such as fewer lung problems, formula might be more effective for growth in these tiny infants. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for preterm and very low birth weight infants who are over 1,250 grams and at least 28 days old. They should currently be on a diet of donor human milk with or without their mother's own milk.

Inclusion Criteria

I weigh more than 1,250 grams.

I am expected to live for at least another 28 days.

My baby is fed with donor human milk, with or without my own milk.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants transition from donor human milk to preterm infant formula after the first month of life

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

32 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Preterm Infant Formula

Trial Overview The study is testing the safety and effectiveness of transitioning from donor human milk to preterm infant formula after the first month of life. It aims to see if this switch can improve growth in terms of weight, length, and fat-free mass accumulation in these infants.

How Is the Trial Designed?

Group I: Donor Milk Active Control 1 Intervention

Group II: Preterm Infant Formula Active Control 1 Intervention

Who Is Running the Clinical Trial?

Augusta University

Lead Sponsor

Trials

219

Recruited

85,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8613713/

Preterm nutrition and neurodevelopmental outcomes - PMC Survival of preterm infants has been steadily improving in recent years because of many recent advances in perinatal and neonatal medicine.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0378378223001767

Outcomes in very preterm infants receiving an exclusive ... This study compared unfortified pasteurised human donor milk and formula supplements. The principal outcome was survival to 34w postmenstrual age without ...

3. publications.aap.org publications.aap.org/pediatrics/article/150/Supplement%201/e2022057092D/188643/Mother-s-Own-Milk-Compared-With-Formula-Milk-for

Mother's Own Milk Compared With Formula ... For preterm infants receiving exclusive human milk, there was an improvement in bronchopulmonary dysplasia compared with exclusive formula-fed ...

4. mdpi.com mdpi.com/2072-6643/14/9/1724

Efficacy of Donated Milk in Early Nutrition of Preterm Infants Data from Yu et al. [12] showed that formula was significantly superior to donated breast milk in terms of weight gain and body length growth in preterm infants ...

5. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2023.1146089/full

Growth of late preterm infants fed nutrient-enriched formula ... We aimed to compare the effects of nutrient-enriched formula with standard term formula on rate of body weight gain of late preterm infants appropriately grown ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10828950/

Neurodevelopmental Outcomes of Extremely Preterm ... Among preterm infants, maternal milk feeding during the birth hospitalization has been associated with better neurodevelopmental outcomes than ...

7. who.int who.int/news-room/fact-sheets/detail/preterm-birth

Preterm birth Approximately 900 000 children die in 2019 of complications of preterm birth (1).

8. nature.com nature.com/articles/s41372-025-02277-2

The fifty billion dollar question: does formula cause ... Research supporting the hypothesis that toxic components in infant formula cause NEC is limited to preclinical data while data from human infants are lacking.

9. jn.nutrition.org jn.nutrition.org/article/S0022-3166(22)15159-X/fulltext

Nutrient Requirements For Preterm Infant Formulas Advances in the care of preterm-LBW infants, including improved nutrition, have reduced mortality rates for these infants from 9.6 to 6.2% from 1983 to 1997.