Feeding Practices for Premature Infants

Overseen By Rajeev Kumar, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Rajeev Kumar

Disqualifiers: Gestational age > 34 weeks, invasive ventilation, major congenital anomalies

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two feeding methods to determine which helps premature infants reach full feeding faster. It compares bolus feeding, where nutrients are given at intervals, to continuous feeding, where nutrients are provided steadily over 24 hours. The trial focuses on preterm babies on non-invasive breathing support who are not currently eating by mouth. Parents of preterm infants born between 24 and 34 weeks, using devices like CPAP or high-flow nasal cannula for breathing, might consider this trial. As an unphased trial, it offers a unique opportunity for parents to contribute to important research that could improve feeding methods for preterm infants.

Do I have to stop taking my current medications for the trial?

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

What prior data suggests that these feeding methods are safe for premature infants?

Research has shown that both bolus and continuous feeding methods are generally safe for premature babies. Early studies suggest that bolus feeding, which involves giving nutrition in intervals, helps babies grow faster and leave the hospital sooner. Specifically, a study of very low birth weight babies found this method effective.

Continuous feeding, where nutrition is given at a steady rate, also offers benefits by providing important nutrients to premature babies. However, some reviews note that it might take longer for babies to reach full feeding levels compared to bolus feeding.

Overall, both methods are well-tolerated, with recent studies highlighting no major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two different feeding methods for premature infants: bolus feeding and continuous feeding. Unlike traditional feeding practices, which often vary in timing and delivery, bolus feeding provides nutrition in intervals every few hours, while continuous feeding ensures a consistent flow of nutrition over 24 hours. These methods aim to tailor nutrition according to the infant's weight and needs, potentially improving growth and health outcomes for premature babies. This trial could help determine the most effective feeding strategy, paving the way for better standard feeding protocols for these vulnerable infants.

What evidence suggests that this trial's feeding methods could be effective for premature infants?

This trial compares two methods of feeding preterm infants: bolus feeding and continuous feeding. Research has shown that both methods have advantages and disadvantages. Bolus feeding, which provides nutrition at set times, helps very low birth weight infants start feeding more effectively. Studies have demonstrated that infants fed this way reach full feeding slightly faster than those on continuous feeding. Continuous feeding delivers a steady flow of nutrition over 24 hours. Although it ensures a constant nutrient supply, it often takes longer for infants to reach full feeds compared to bolus feeding. This trial continues to study both methods to determine the best way to nourish preterm babies. ^{2 3 6 7 8}

Who Is on the Research Team?

Rajeev Kumar, MD

Principal Investigator

Cook County Health

Are You a Good Fit for This Trial?

This trial is for preterm infants between 24-34 weeks of gestation who are not eating by mouth or only receiving minimal feeds and require non-invasive breathing support. Infants with major birth defects, those on invasive ventilation, or older than 34 weeks gestational age cannot participate.

Inclusion Criteria

My baby was born between 24 and 34 weeks of pregnancy.

Nothing by mouth (NPO) or on trophic feeds (<20 ml/kg/day) at the time of randomization.

I am using a machine to help with my breathing.

Exclusion Criteria

My infant is on a ventilator or nasal cannula and is being fed more than minimal amounts.

You were born with major physical abnormalities.

You are more than 34 weeks pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Infants are randomized to receive either continuous nasogastric feeding or intermittent bolus feeds

Up to 1 year

Continuous monitoring in NICU

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Method of feeding

Trial Overview

The study aims to determine the best feeding method for premature babies needing respiratory support. It compares two approaches: giving food in small amounts at intervals (intermittent bolus feeds) versus a steady flow of nutrition (continuous feeds).

How Is the Trial Designed?

Group I: Continuous Feeding Experimental Treatment 1 Intervention

Continuous feeding will be defined as delivering enteral nutrition with constant speed for 24 hours via a nutritional pump. It will be further stratified as per weight ( less than 1000 g, 1000-1500 g, \>1500 g).

Group II: Bolus Feeding Experimental Treatment 1 Intervention

Intermittent bolus feeding will be defined as delivering enteral nutrition multiple times, usually every 2-3 hours over 15 - 30 minutes by gravity or an electric pump. It will be further stratified as per weight ( less than 1000 g, 1000-1500 g, \>1500 g).

Who Is Running the Clinical Trial?

Rajeev Kumar

Lead Sponsor

Trials

1

Recruited

50+

Published Research Related to This Trial

Early enteral feeding within 48 hours after birth and progressive feeding before 4 days of life in clinically stable very preterm and very low birthweight infants is safe and does not increase the risk of necrotising enterocolitis (NEC) or mortality.

There is limited evidence for feeding practices in high-risk infants, such as those born small for gestational age, and future studies should focus on objective outcomes to reduce bias in assessing the safety and efficacy of enteral feeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early enteral feeding in preterm infants. Kwok, TC., Dorling, J., Gale, C.[2020]

Enteral nutrition is preferred over total parenteral nutrition (TPN) for preterm infants because it reduces risks associated with catheter use and TPN complications, promoting better long-term health outcomes.

For preterm infants weighing less than 1500 g, tube feeding (either orogastric or nasogastric) is essential, with continuous feeding recommended for those under 1250 g or with health issues, while stable infants can be fed intermittently like term infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enteral nutrition for preterm infants: by bolus or continuous? An update. Bozzetti, V., Tagliabue, PE.[2018]

Early growth deficits in preterm infants due to suboptimal nutrition can lead to long-term issues like short stature and poor neurodevelopment, highlighting the importance of effective feeding strategies in neonatal care.

Initiating enteral feeding with preterm breast milk, supplemented with human milk fortifiers, is crucial for promoting gut health and reducing complications, but more large-scale studies are needed to assess the long-term effects of these nutritional interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extrauterine growth restriction in preterm infants: importance of optimizing nutrition in neonatal intensive care units. Yu, VY.[2008]

Rapid advancement of enteral feedings in low-birth-weight premature infants led to a shorter time to achieve full enteral feeding and regain birth weight, based on a systematic review of randomized trials.

There was no significant increase in the risk of necrotizing enterocolitis with faster feeding rates, but the safety of this approach remains uncertain due to broad confidence intervals and limited data on hospital stay length.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid versus slow rate of advancement of feedings for promoting growth and preventing necrotizing enterocolitis in parenterally fed low-birth-weight infants. Kennedy, KA., Tyson, JE., Chamnanvanakij, S.[2018]

A study of 293 preterm infants under 1500 g birthweight showed that implementing a rapid enteral feeding protocol led to faster achievement of full feedings and earlier weight regain without increasing the risk of feeding-related complications.

Infants in the rapid feeding group were more successfully stabilized on noninvasive ventilation and did not require mechanical ventilation, indicating that this feeding approach is safe and effective for improving clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compatibility of rapid enteral feeding advances and noninvasive ventilation in preterm infants-An observational study. Behnke, J., Estreich, V., Oehmke, F., et al.[2022]

A systematic review found only one small study (31 infants) comparing push versus gravity feeding methods for gavage feeding in preterm or low birth weight infants, which did not report the primary outcome of time to establish full feeding.

The evidence regarding the effects of push versus gravity feeding on respiratory and heart rates was very uncertain, indicating that more research is needed to determine the safety and efficacy of these feeding methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Push versus gravity for intermittent bolus gavage tube feeding of preterm and low birth weight infants. Dawson, JA., Summan, R., Badawi, N., et al.[2023]

In a study of 110 preterm newborns, different feeding methods (breastfeeding, spoon feeding, and gavage feeding) significantly affected vital parameters like respiratory rate and oxygen saturation, but not pulse rate, during a 3-hour monitoring period.

No adverse effects such as chest indrawing or nasal flaring were observed after any feeding method, indicating that these feeding techniques are safe for physiologically stable preterm newborns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Pulse Rate, Oxygen Saturation, and Respiratory Effort after Different Types of Feeding Methods in Preterm Newborns. Patel, DV., Shah, D., Kantharia, KA., et al.[2022]

Gastric bolus feeding is the preferred method for enteral feeding in most newborns due to its practicality and cost-effectiveness, while continuous gastric feeding may be better for unstable preterm infants or those with severe respiratory issues.

Early low-volume feedings are beneficial and safe, with daily increases of 10-20 ml/kg not linked to a higher risk of necrotizing enterocolitis, making them a safe approach for establishing enteral nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Techniques of enteral feeding in the newborn. Macagno, F., Demarini, S.[2019]

Trophic feedings, which are early small-volume feedings, help preterm infants receive essential nutrition and lead to earlier full feedings and discharge from the NICU, supporting their growth and development.

Recent studies indicate that both intermittent bolus feedings and continuous infusions can be beneficial for high-risk infants, with safe feeding volumes being established even for extremely premature infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feeding the ill or preterm infant. Anderson, DM.[2006]

There is currently insufficient evidence to determine whether push or gravity gavage feeding is more effective for establishing full tube feeds in preterm or low birth weight infants, as only one small study was found that did not provide conclusive results.

The study suggests that a larger, well-designed randomized trial is necessary to properly evaluate the benefits and risks of each feeding method, taking into account factors like gestational age and birth weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Push versus gravity for intermittent bolus gavage tube feeding of premature and low birth weight infants. Dawson, JA., Summan, R., Badawi, N., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7222868/

Continuous feeding versus intermittent bolus ...

Clinical risks and advantages of both continuous feeding and intermittent feeding for preterm infants have been presented in previous studies.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03961139

Continuous Versus Intermittent Bolus Feeding in Very ...

A Cochrane review in 2011 of continuous intra-gastric versus intermittent bolus intra-gastric feeding for premature infants found conflicting results, and was ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34165778/

Continuous nasogastric milk feeding versus intermittent ...

Continuous feeding may result in little to no difference in rate of gain in length compared with intermittent feeding (MD 0.02 cm/week, 95% CI - ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1527336916300563

Feeding in the NICU: Comparing Bolus and Continuous ...

The debate regarding the best feeding method for premature infants is ongoing. Should they be nourished by bolus or continuous feeding?

5.

hopkinsmedicine.org

hopkinsmedicine.org/-/media/files/allchildrens/clinical-pathways/early-enteral-nutrition-6_14_23.pdf

Early Standardized Enteral Nutrition Management of the ...

Bolus vs continuous feeds – In a study of 28 VLBW infants, gravity bolus feeds were more effective than continuous feeds to promote feeding ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10898621/

Bolus Feeding Via Gastric Versus Oral Routes in Very Preterm ...

Oral bottle feeding accelerates postnatal catch-up growth and full enteral nutrition acquisition while reducing hospitalization duration.

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0146000519300850

Early enteral feeding in preterm infants

Trials targeting such high-risk preterm infants have demonstrated that progressive enteral feeding started in the first 4 days is safe and does not lead to ...

8.

eoeneonatalpccsicnetwork.nhs.uk

eoeneonatalpccsicnetwork.nhs.uk/wp-content/uploads/2021/10/Enteral-Feeding-guideline.pdf

Enteral Feeding of Preterm Infants on the Neonatal Unit.

Current data do not provide evidence that slow advancement of feeding in very low birth weight infants reduces the risk of NEC (12,13,14,15,16) however ...