Transpyloric Feeding for Very Low Birth Weight Infants

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

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment 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 weight, as it was associated with better weight gain and reduced mortality rates without serious complications. ^{1 2 3 4 5}

Is transpyloric feeding safe for very low birth weight infants?

Transpyloric feeding in very low birth weight infants has been associated with some complications, such as necrotizing enterocolitis (a serious intestinal disease), but it is generally considered a simple and well-tolerated technique. Some studies found no serious complications with nasoduodenal feeding, a similar method, and noted benefits like reduced mortality rates and better weight gain. ^{1 4 6 7 8}

How does the treatment of transpyloric feeding differ from other treatments for very low birth weight infants?

Transpyloric feeding involves placing the feeding tube into the upper small bowel, which can prevent the risk of aspiration (inhaling food into the lungs) after vomiting and may lead to more rapid weight gain compared to nasogastric feeding, where the tube is placed in the stomach. ^{1 6 9 10 11}

What is the purpose of this trial?

Premature infants have high rates of bronchopulmonary dysplasia (BPD) due to prematurity of the participants' lungs and the need for prolonged respiratory support. These infants are at increased risk for gastroesophageal reflux and aspiration which may exacerbate lung injury. Transpyloric feeds, specifically duodenal feeds, may be used to bypass the stomach and directly feed the duodenum decreasing the amount of gastric reflux contributing to aspiration. Duodenal feeds are equivalent to gastric feeds with regards to nutritional outcomes, and have been shown to decrease events of apnea and bradycardia in premature infants. This study will evaluate the feasibility and safety of duodenal feeds in premature infants. The hypothesis is that duodenal feeds may be safely and successfully performed in premature very low birth weight infants.

Research Team

Noura Nickel, MD

Principal Investigator

Johns Hopkins All Children's Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Randomised trial of continuous nasogastric, bolus nasogastric, and transpyloric feeding in infants of birth weight under 1400 g. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Nasogastric compared with nasoduodenal feeding in low birthweight infants. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

Prospective evaluation of a new through-the-scope nasoduodenal enteral feeding tube. [2019]

4. Sweden pubmed.ncbi.nlm.nih.gov

Nasoduodenal feeding in high risk newborns. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Systematic review of transpyloric versus gastric tube feeding for preterm infants. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Transpyloric feeding in small preterm infants. [2019]

7. England pubmed.ncbi.nlm.nih.gov

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

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

Transpyloric tube feeding in very low birthweight infants with suspected gastroesophageal reflux: impact on apnea and bradycardia. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Transpyloric versus gastric tube feeding for preterm infants. [2018]

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

Transpyloric versus gastric tube feeding for preterm infants. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Transpyloric versus gastric tube feeding for preterm infants. [2020]