Transpyloric Feeding for Very Low Birth Weight Infants

Recruiting at 1 trial location

Overseen By Noura Nickel, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins All Children's Hospital

Must not be taking: Hydrocortisone

Disqualifiers: Low pH, Low APGAR, IUGR, congenital anomalies, others

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: 1

Duration: Up to 15 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a special feeding method for very small premature infants. The focus is on duodenal feeds, which deliver food directly to the intestine and may reduce lung problems caused by stomach reflux. Researchers aim to determine if this method can safely assist infants who struggle with traditional feeding due to their small size and early birth. Infants admitted to a specific NICU with a birth weight under 1251 grams may qualify as candidates. As an unphased study, this trial provides a unique opportunity to contribute to innovative research that could enhance feeding methods for premature infants.

Will I have to stop taking my current medications?

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

What prior data suggests that transpyloric feeding is safe for very low birth weight infants?

Research has shown that feeding directly into the small intestine, known as transpyloric feeding, is safe for very low birth weight infants. Studies suggest this method can reduce breathing pauses (apnea) and slow heart rates (bradycardia) in premature babies. It can also lessen the need for machines to assist with breathing and may lower the risk of lung problems like bronchopulmonary dysplasia. Overall, transpyloric feeding serves as a safe alternative to traditional feeding methods, especially when using human milk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new feeding technique for very low birth weight infants. Unlike the standard gastric feeding method, which delivers nutrition to the stomach, this trial is investigating duodenal feeding, where nutrients are delivered directly to the duodenum, a part of the small intestine. This approach could potentially improve nutrient absorption and digestion, bypassing the stomach and reducing the risk of complications like reflux. By comparing these two methods, researchers hope to find out if duodenal feeding offers significant benefits in terms of growth and overall health for these fragile infants.

What evidence suggests that transpyloric feeding is effective for very low birth weight infants?

Research has shown that feeding preterm infants directly into the small intestine, known as transpyloric feeding, can reduce breathing pauses and slow heart rates. In this trial, participants in the "Duodenal Feeds" arm will receive feeds via this experimental route. This method is particularly beneficial for newborns at high risk, such as those with very low birth weight. By bypassing the stomach, it reduces the risk of food refluxing into the lungs, which can be harmful. However, concerns exist about potential risks, such as difficulty digesting food and necrotizing enterocolitis, a serious intestinal disease. Overall, feeding directly into the small intestine appears promising for improving breathing and heart rate stability in preterm infants. ^{1 5 6 7 8}

Who Is on the Research Team?

Noura Nickel, MD

Principal Investigator

Johns Hopkins All Children's Hospital

Are You a Good Fit for This Trial?

This trial is for premature infants weighing less than 1251 grams at birth, admitted to the NICU within 72 hours of life. It's not suitable for babies who haven't started feeding by day 10, those on certain medications, with growth restrictions, very low APGAR scores, intestinal issues or congenital anomalies.

Inclusion Criteria

My baby was born weighing less than 1251 grams.

Babies who are brought to Johns Hopkins All Children's NICU within 3 days of being born.

Exclusion Criteria

My infant had intestinal issues or NEC.

Your blood pH is less than 7.0.

My infant has a birth defect, such as heart issues or structural problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Infants are randomized to receive either duodenal or gastric feeds once they advance past 50mL/kg/day of enteral feeds.

Up to 15 months

Continuous monitoring during hospitalization

Follow-up

Participants are monitored for safety and effectiveness after treatment, including primary and secondary outcomes.

Up to 15 months or until discharge

Frequent monitoring during hospitalization

What Are the Treatments Tested in This Trial?

Interventions

• Mode of Delivery of Feeds

Trial Overview The study tests if duodenal feeds (bypassing the stomach to feed directly into the small intestine) can be done safely and effectively in very low birth weight infants to reduce lung complications associated with prematurity and traditional gastric feeding methods.

How Is the Trial Designed?

Group I: Duodenal Feeds Experimental Treatment 1 Intervention

Patients in this arm will receive feeds via the experimental route which is duodenal feeds.

Group II: Gastric Feeds Active Control 1 Intervention

Patients in this arm will receive feeds via the standard route which is gastric feeds.

Who Is Running the Clinical Trial?

Johns Hopkins All Children's Hospital

Lead Sponsor

Trials

47

Recruited

5,009,000+

Published Research Related to This Trial

In a study of 20 preterm infants, those fed transpylorically with expressed human milk experienced higher fluid intakes and more rapid weight gain compared to a control group fed via nasogastric tube.

Transpyloric feeding is safer as it reduces the risk of aspiration after vomiting, making it a beneficial feeding method for small preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transpyloric feeding in small preterm infants. Wolfsdorf, J., Makarawa, S., Fernandes, C., et al.[2019]

A systematic review of nine trials involving 359 preterm infants found no significant benefits of transpyloric feeding over gastric feeding in terms of feeding tolerance or growth rates.

However, transpyloric feeding was associated with a higher risk of gastrointestinal disturbances and increased mortality, suggesting potential harm, though these results should be interpreted cautiously due to methodological weaknesses in the studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transpyloric versus gastric tube feeding for preterm infants. Watson, J., McGuire, W.[2021]

A systematic review of nine trials found no significant benefits of transpyloric feeding over gastric feeding in preterm infants regarding short-term growth rates or long-term growth outcomes.

Transpyloric feeding was associated with a higher incidence of gastrointestinal disturbances and a potential increase in mortality, suggesting it is not a recommended practice for preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transpyloric versus gastric tube feeding for preterm infants. McGuire, W., McEwan, P.[2020]

In a study of 100 infants weighing less than 1500 g at birth, both intermittent nasogastric and continuous nasoduodenal feeding regimens showed no significant differences in calorie intake or growth rates over seven weeks.

Given the increased complexity and radiological exposure associated with nasoduodenal feeding, nasogastric feeding is suggested as the preferred method for feeding low birthweight infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasogastric compared with nasoduodenal feeding in low birthweight infants. Laing, IA., Lang, MA., Callaghan, O., et al.[2019]

Transpyloric feeding in preterm infants was associated with a higher risk of gastrointestinal disturbances and increased mortality compared to gastric feeding, indicating potential safety concerns.

The systematic review of eight trials found no evidence that transpyloric feeding improved growth or development in preterm infants, suggesting it is not a beneficial feeding method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of transpyloric versus gastric tube feeding for preterm infants. McGuire, W., McEwan, P.[2019]

Transpyloric feeding was evaluated in 46 very ill newborn infants on assisted ventilation and was found to be a simple and well-tolerated technique.

However, there was a notable risk of necrotising enterocolitis in 4 infants, highlighting a potential complication associated with this feeding method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transpyloric feeding in 49 infants undergoing intensive care. Dryburgh, E.[2019]

Transpyloric tube feeding significantly reduced episodes of apnea and bradycardia in very low birthweight infants with signs of gastroesophageal reflux, with apnea episodes decreasing from 4.0 to 2.5 and bradycardia episodes from 7.2 to 4.5 after treatment.

The study found that transpyloric feeding was generally safe, with a low incidence of necrotizing enterocolitis (6.9%) and no cases of late-onset sepsis, particularly when human milk was used, suggesting a potential therapeutic benefit for these vulnerable infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transpyloric tube feeding in very low birthweight infants with suspected gastroesophageal reflux: impact on apnea and bradycardia. Malcolm, WF., Smith, PB., Mears, S., et al.[2021]

The new nasoduodenal feeding tube placement technique using a therapeutic gastroscope was successful in all 21 patients, demonstrating a reliable method for accessing the small bowel.

The procedure took an average of 31 minutes and allowed for tube use for over 9 days, confirming safety and efficacy in placing the tube in the distal duodenum or proximal jejunum.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective evaluation of a new through-the-scope nasoduodenal enteral feeding tube. Damore, LJ., Andrus, CH., Herrmann, VM., et al.[2019]

In a study involving 43 infants weighing under 1400 g, transpyloric feeding was associated with more complications and did not show any benefits in growth rate or nutritional indices compared to other feeding methods.

Bolus and continuous nasogastric feeding methods are recommended as better routine practices for low birth weight infants, as they resulted in fewer complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised trial of continuous nasogastric, bolus nasogastric, and transpyloric feeding in infants of birth weight under 1400 g. Macdonald, PD., Skeoch, CH., Carse, H., et al.[2019]

A systematic review of eight trials found no significant benefits of transpyloric feeding over gastric feeding in preterm infants regarding growth rates or development, indicating that both methods are similar in effectiveness.

Transpyloric feeding was associated with a higher incidence of gastrointestinal disturbances and a potential increase in mortality, suggesting that this method may pose more risks than gastric feeding for preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transpyloric versus gastric tube feeding for preterm infants. McGuire, W., McEwan, P.[2018]

Nasoduodenal feeding in high-risk newborns, particularly those with low birth weight, effectively prevents the typical weight loss seen in the first week of life and promotes better weight gain compared to other feeding methods.

The introduction of nasoduodenal feeding led to a significant reduction in mortality rates from 18% to 11.4% in the neonatal unit, with no serious complications reported, highlighting its safety and efficacy for infants weighing 1500 g or less.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasoduodenal feeding in high risk newborns. Minoli, I., Moro, G., Ovadia, MF.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2827248/

TRANSPYLORIC TUBE FEEDING IN VERY LOW ... Transpyloric feedings, especially when limited to human milk, may safely reduce episodes of apnea and bradycardia in preterm infants with suspected ...

2. withpower.com withpower.com/trial/phase-premature-birth-7-2020-f1528

Transpyloric Feeding for Very Low Birth Weight Infants The research suggests that nasoduodenal feeding, a component of transpyloric feeding, is effective for high-risk newborns, particularly those with low birth ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/19242488/

Transpyloric tube feeding in very low birthweight infants with ... Transpyloric feedings, especially when limited to human milk, may safely reduce episodes of apnea and bradycardia in preterm infants with suspected GER.

4. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2024.1496620/full

Use of transpyloric feeds in extremely low birth weight ... Additionally, there is concern that TpF may be associated with an increased risk of necrotizing enterocolitis (NEC), feeding intolerance, and ...

5. adc.bmj.com adc.bmj.com/content/61/2/138

Nasogastric compared with nasoduodenal feeding in low ... One hundred successive infants weighing less than 1500 g at birth were allocated alternately to intermittent nasogastric or continuous nasoduodenal feeding ...

6. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2024.1496620/epub

Use of transpyloric feeds in extremely low birth weight ... Early TpF initiated within the first week after birth has shown a reduced risk of death or BPD, fewer days of mechanical ventilation, fewer ...

7. scholarlycommons.hcahealthcare.com scholarlycommons.hcahealthcare.com/cgi/viewcontent.cgi?article=1417&context=hcahealthcarejournal

Transpyloric Feed in Reflux-Associated Apnea in Preterm ... The en- rolled neonates underwent continuous transpyloric tube feeding for 72 hours. The primary outcome measure was the difference in the number of apneic ...

8. mdpi.com mdpi.com/1648-9144/61/8/1481

Optimizing Endoscopic Transpyloric Feeding Tube ... However, more recent studies have reported that early TP tube feeding may offer a safer alternative to nasogastric (NG) feeding, particularly in extremely low ...