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Completed

NCT Number: NCT01420263

Re-feeding Gastric Residuals in Preterm Infants

The purpose of this study is to determine whether re-feeding of gastric residuals reduces the time needed to establish full enteral feedings in premature infants. Infants with gestational ages 23-28 weeks at birth will be randomized within one week to receive either gastric residuals or fresh formula or breastmilk whenever significant residuals during feeding advancement require clinical assessment for continuing feedings. Primary outcome measure is time to establish full enteral feedings (120cc/kg/day).

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Key information

Conditions

Premature; Infant, Light-for-dates Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 day–7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

About this study

Infants with gestational ages 23-28 weeks at birth will be randomized within one week to receive either gastric residuals or fresh formula or breastmilk whenever significant residuals during feeding advancement require clinical assessment for continuing feedings. Feeding advancement determined by clinical physicians.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gestational age between 23.0 and 28.6 weeks;
  • Receiving intravenous fluids but not enteral nutrition more than trophic feeds;
  • Written informed consent from the parents

Exclusion criteria

  • Major congenital/chromosomal anomalies;
  • Moribund infant with low likelihood of survival, in the opinion of the clinical team

Treatment and study plan

Re-feeding residuals

Procedure

In the presence of significant gastric residuals (more than 1/3 of previous feed or > 2ml), residual volumes will be re-fed if the physician decision is to continue feeds as scheduled in the absence of other clinical signs and symptoms of feeding intolerance. This practice will be continued until full enteral feeding is achieved and maintained for a minimum of 48 hours.

Fresh Feeding Breastmilk or Formula only

Procedure

In the presence of significant gastric residuals (more than 1/3 of previous feed or > 2ml), residual volumes will be discarded and fresh breastmilk or formula will be fed if the physician decision is to continue feeds as scheduled in the absence of other clinical signs and symptoms of feeding intolerance. This practice will be continued until full enteral feeding is achieved and maintained for a minimum of 48 hours.

Primary outcomes

  1. Time to establish full enteral feeding

    Time frame: Birth to 28 days

    Time required to reach enteral feeding at 120cc/kg/day

Secondary outcomes

  1. Feeding intolerance

    Time frame: Birth to 28 days

    Feeding intolerance defined as interruption or cessation of enteral feeds for a perod greater than 12 hours for presence of bloody gastric residuals or an abnormal abdominal examination.

  2. Episodes of feeding intolerance resulting in a interruption or cessation of progression of enteral feeds for a period of < 12 hours.

    Time frame: Birth to 28 days

    Number of episodes of feeding intolerance resulting in an interruption or cessation of progression of enteral feedings for a period of < 12 hours.

  3. Number of days receiving parenteral nutrition

    Time frame: Birth to 28 days

    Total number of days or partial day receiving parenteral nutrition

  4. Duration of hospital stay

    Time frame: Birth to 120 days or discharge, whichever occurs first.

    Length of hospital stay in days

  5. Diagnosis of necrotizing enterocolitis

    Time frame: Birth to 120 days or discharge, whichever occurs first.

    Diagnosis of necrotizing enterocolitis, Bell's Staging II-IV

  6. Diagnosis of intestinal perforation

    Time frame: Birth to 120 days or discharge, whichever occurs first

    Diagnosis of intestinal perforation between birth and 120 days or discharge, whichever occurs first.

  7. Death

    Time frame: Birth to 120 days

    Death prior to 121 days of age.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Re-feeding Residuals Versus Feeding Fresh Formula/Milk for Feeding Intolerance in Premature Infants

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Aug 19, 2011
Registry last updated
Feb 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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