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Completed

NCT Number: NCT01787019

Initiation of Oral Feeding at 30 Versus 33 Weeks Postmenstrual Age

The purpose of the study is to determine if earlier initiation of oral (by mouth as opposed to tube) feedings in premature infants results in earlier attainment of full oral feedings and/or discharge.

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Key information

Age range

Up to 7 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Children's Memorial Hermann Hospital

Houston, Texas, 77030, United States

About this study

Infants will be enrolled and randomized at 30 0/7 weeks postmenstrual age. The Earlier Oral Feeding group will initiate oral feedings at 30 0/7 weeks postmenstrual age. The Later Oral Feeding group will initiate oral feedings at 33 0/7 weeks postmenstrual age. The number of oral feeding attempts will be advanced according to a feeding progression protocol for both groups. Successful completion of a feeding is defined as oral completion of the full volume of a feeding within 30 minutes, without a bradycardic episode (heart rate <100 beats per minute) or desaturation (oxygen saturation decrease >5% from baseline values). If infant does not successfully complete >95% of the total prescribed volume of a feeding, the remainder of the volume will be supplied via gastric tube. All oral feedings will be performed by bedside nurses, or by a parent with observation by the nursing staff, with continuous cardiorespiratory and pulse oximetry monitoring. Individual oral feeding attempts for both groups will continue until one of the following occurs despite appropriate pacing of the feeding: 1) the feeding is completed 2) feeding duration of 30 minutes 3) adverse event during a feeding [multiple bradycardic episodes (3 episodes of heart rate <100 beats per minute), bradycardia with choking episode, single severe bradycardia (heart rate <60)]. If the infant experiences an adverse event during an oral feeding attempt, oral feeding attempts will be held for 2 days.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Gestational age <= 29 weeks at birth
  • Tolerating enteral feedings for at least 3 days before 30 weeks postmenstrual age

Exclusion criteria

  • Neurologic, cardiac, respiratory, or gastrointestinal disorders that interfere with oral feeding

Treatment and study plan

oral feeding

Other

Primary outcomes

  1. Postmenstrual age at full oral feeding

    Time frame: until hospital discharge (typically 36 weeks postmenstrual age)

    defined as the infant orally consuming the volume of formula/breastmilk as prescribed by the attending physician without requiring gavage feedings for 2 days

Secondary outcomes

  1. postmenstrual age at discharge

    Time frame: until hospital discharge (typically 36 weeks postmenstrual age)

  2. growth between enrollment and 36 weeks postmenstrual age

    Time frame: until hospital discharge (typically 36 weeks postmenstrual age)

Other outcomes

  1. average FiO2

    Time frame: at 33 weeks postmenstrual age

  2. use of positive pressure (yes/no)

    Time frame: 33 weeks postmenstrual age

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 8, 2013
Registry last updated
May 13, 2016

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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