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

46 Participants Needed

Trial Summary

What is the purpose of this trial?

To evaluate the duration to reach full feeds by comparing continuous gavage feeds versus bolus feeds in preterm infants who are on non-invasive respiratory support (RAM cannula - short binasal prongs).

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 data supports the idea that Feeding Practices for Premature Infants is an effective treatment?

The available research shows that early, small-volume feedings, known as trophic feedings, help premature infants achieve full nutritional feedings sooner and allow for earlier discharge from the hospital. Studies indicate that early enteral feeding, which involves feeding through a tube, can be safely started within the first few days of life without increasing the risk of serious conditions like necrotizing enterocolitis or mortality. Continuous feeding might be better for smaller or less stable infants, while intermittent feeding is suitable for stable ones. Overall, these feeding practices help support growth and development in premature infants. ^{1 2 3 4 5}

What safety data exists for feeding practices in premature infants?

Safety data for feeding practices in premature infants indicate that early low-volume feedings are beneficial and not associated with increased morbidity. Progressive enteral feeding started within the first 4 days is safe for clinically stable very preterm and very low birthweight infants, without higher mortality or incidence of necrotizing enterocolitis (NEC). However, this may not apply to high-risk infants. Both bolus and continuous gavage feeding are used, but there is little evidence to support one as superior. Safe volumes for even extremely premature infants have been reported, though optimal volumes are still under investigation. Rapid advancement of feedings may increase NEC risk, while slow advancement could lead to undernutrition. ^{1 2 5 6 7}

Is the method of feeding a promising treatment for premature infants?

Yes, the method of feeding, including gavage feeding, bolus feeding, and continuous feeding, is promising for premature infants. It helps provide necessary nutrition for growth and development, supports earlier discharge from the hospital, and can be adjusted to meet the needs of each infant. ^{1 7 8 9 10}

Research Team

Rajeev Kumar, MD

Principal Investigator

Cook County Health

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Feeding the ill or preterm infant. [2006]

2. United States pubmed.ncbi.nlm.nih.gov

Early enteral feeding in preterm infants. [2020]

3. Italy pubmed.ncbi.nlm.nih.gov

Enteral nutrition for preterm infants: by bolus or continuous? An update. [2018]

4. Croatia pubmed.ncbi.nlm.nih.gov

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

5. Norway pubmed.ncbi.nlm.nih.gov

Techniques of enteral feeding in the newborn. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Compatibility of rapid enteral feeding advances and noninvasive ventilation in preterm infants-An observational study. [2022]

7. England 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. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Push versus gravity for intermittent bolus gavage tube feeding of premature and low birth weight infants. [2021]

9. Egypt pubmed.ncbi.nlm.nih.gov

Evaluation of Pulse Rate, Oxygen Saturation, and Respiratory Effort after Different Types of Feeding Methods in Preterm Newborns. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Push versus gravity for intermittent bolus gavage tube feeding of preterm and low birth weight infants. [2023]