Progressive Feeding without MEF for Premature Birth

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Alabama at Birmingham, Birmingham, AL
Premature Birth+1 More
Progressive Feeding without MEF - Other
Eligibility
< 18
All Sexes
Eligible conditions
Premature Birth

Study Summary

This study is evaluating whether a feeding method can improve the survival of extremely preterm infants.

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Eligible Conditions

  • Premature Birth
  • Infant; Premature, Light-For-Dates

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Progressive Feeding without MEF will improve 1 primary outcome and 13 secondary outcomes in patients with Premature Birth. Measurement will happen over the course of birth to 14 days.

birth to 120 days
Death
Day 120
Duration of hospital stay in days
Growth/length at time of discharge
Number of episodes of culture proven sepsis
Number of participants with diagnosis of necrotizing enterocolitis
birth to 14 days
Number of participants with diagnosis of intestinal perforation
birth to 28 days
Changes in intestinal microbiome
Number of days alive and receiving full enteral feeding
Number of days alive and receiving full enteral feeding according to time of exposure to human milk and formula feeding the first 28 days
Number of days receiving parenteral nutrition
Number of days requiring central line access
Number of episodes of feeding intolerance
Number of episodes of feeding intolerance resulting in an interruption or cessation of progressive enteral feeding for a period < 12 hours
Time to establish full enteral feeding

Trial Safety

Trial Design

2 Treatment Groups

Progressive Feeding with MEF
Progressive Feeding without MEF

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. Progressive Feeding Without MEF is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Progressive Feeding without MEF
Other
This group will receive feeding volumes of 20-24ml/kg/d of day 1 of feeding followed by the study intervention of daily volume increases in increments of 24-25ml/kg/d as tolerated until full enteral feeding is achieved.
Progressive Feeding with MEF
Other
This group will receive minimal enteral feeds (MEF) with volumes of 20-24ml/kg/d for 4 days followed by daily increases in increments of 24-25ml/kg/d as tolerated until full enteral feeding is achieved.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: birth to 120 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly birth to 120 days for reporting.

Who is running the study

Principal Investigator
A. A. S.
Ariel A. Salas, Principal Investigator
University of Alabama at Birmingham

Closest Location

University of Alabama at Birmingham - Birmingham, AL

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
admission to the NICU within 48 hours with gestational age between 22.0 and 28.6 weeks

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is premature birth?

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Premature birth can be accompanied by serious long-term effects such as learning disabilities and behavioral problems later in life. Premature birth imposes a high financial burden on families and society.

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What are the signs of premature birth?

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Babies of mothers who become pregnant at an early baby can be at risk for premature birth. This risk also increases substantially with advancing age, and for a variety of women is highest among those who are first pregnancies.

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How many people get premature birth a year in the United States?

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Every year, an estimated 19,400 babies are born prematurely, making more than one out of five births in the United States very premature. And if the baby survives this premature birth and goes on to have a child, one of the babies will likely be premature too, indicating that the problem of premature birth is not a benign one.

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Can premature birth be cured?

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Premature birth cannot be cured and does not necessarily cause problems later in life. If the baby is otherwise healthy then this is a harmless condition.

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What causes premature birth?

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The premature birth syndrome is still very poorly understood both in its mechanisms and its clinical presentation, with different rates of prematurity in different societies due possibly to genetic and environmental factors.

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What are common treatments for premature birth?

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There are no common treatments associated with increased or decreased mortality rates in cases of preterm birth. Premature birth is the second leading cause of infant mortality globally. In the absence of reliable data regarding the relative safety and efficacy of potential treatments, the need for newborn screening and intervention to prevent such deaths by prematurity should be advocated. There was also no evidence-based indication for routine medical treatment in the antenatal period.

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How serious can premature birth be?

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Premature infants are at increased risks for a variety of complications. It is essential that obstetricians and pediatricians be knowledgeable about these risks and how to assess them through detailed clinical exams. Once a clinical suspicion of prematurity arises, prompt delivery through appropriate techniques such as Cesarean or forceps is indicated. Infants that may need additional monitoring include those with serious intrauterine growth restriction, premature rupture of capillaries, or other congenital defects in which intrauterine growth restriction is a major concern.

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What is progressive feeding without mef?

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For patients with PN, the progressive method, whereby mef gradually decreases because of improved appetite, and is then discontinued, is safe and effective. This protocol is simple and does not increase the risk to patients.

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What are the common side effects of progressive feeding without mef?

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In this retrospective study, we found no new side effect to progressive feeding without mef. We are uncertain which side effects are associated with mef. It would require a well-designed prospective study to answer this question. For patients who were already getting mef, as with any mef complication, patients should consult their physicians for confirmation.

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How does progressive feeding without mef work?

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Progressive feeding with Mef results in improved short- and long-term outcomes and lower cost compared with those prescribed a standardized feeding plan. The impact of feedings on short- and long-term outcome is similar to that of the standardized feeding plan.

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What is the latest research for premature birth?

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The evidence supporting preventive services for premature birth is inconsistent, but more evidence is available for treating premature newborns with phototherapy, and for screening newborns with cord blood tests to detect early-onset neonatal complications. Improving delivery in a resource-limited setting has the potential to improve outcomes for preterm infants. However, many low- and middle-income countries do not have the capacity to implement, evaluate, and disseminate evidence-based interventions that are cost-effective and are likely to be effective. Future research should focus on developing the tools to monitor the implementation and delivery of interventions and on new or improved interventions for premature newborns and their immediate families.

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Have there been other clinical trials involving progressive feeding without mef?

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There have been many clinical trials that show the impact of progressive feeding in the neonatal intensive care unit. While all of the studies agree that progressive feeding enhances weight gain, they disagree in regards to which protocols yield the least medical complications in the neonate and which protocols have greater resource use. While all investigators agree that progressive feeding has its merits, there is still more research to be done.

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