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NCT Number: NCT06569186

Cue-Based Vs. Clinician-Driven Feeding in Very Low Birthweight Infants

In this parallel-group randomized controlled trial, very low birthweight infants will be randomly assigned in a 1:1 ratio to either cue-based (intervention group) or clinician-driven feeding (control group). For infants in the intervention group, Speech therapists and nurses will use their cue-based assessment training to aid in clinical management of oral feeding. For infants in the control group, clinicians caring for these infants will define the feeding plan based on their daily assessment.

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Key information

Conditions

Infant, Very Low Birth Weight Behavior Behavior, Animal Feeding Behavior Feeding Patterns Infant Development

Age range

28 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Birthweight < 1500 grams
  • Gestational age between 28 and 31 weeks of gestation
  • Full enteral feeding established before 32 weeks of postmenstrual age (PMA)
  • Oral feeding initiated before 33 weeks PMA.

Exclusion criteria

  • Major congenital/chromosomal anomalies,
  • Patent ductus arteriosus causing significant cardiovascular symptoms
  • History of necrotizing enterocolitis stage 2 or greater

Treatment and study plan

Cue-based feedings

Behavioral

Speech therapists will use cue-based protocols to guide feeds

Other names: Speech therapy driven feeds

Primary outcomes

  1. Time interval in days from introduction to attainment of independent oral feeding

    Time frame: 4-20 days

Secondary outcomes

  1. Postnatal age at discharge in days

    Time frame: 34 to 40 weeks postnatal age

  2. Length of hospital stay in days

    Time frame: 10-60 days

  3. Average weight gain during the transition from tube to oral feeding

    Time frame: 10-60 days

  4. Total number of tube feeding events per infant during the transition from tube to oral feeding

    Time frame: 10-60 days

  5. Follow up phone call

    Time frame: 4-6 months after birth

    A follow-up phone call 3 months after NICU discharge will also be performed to assess long-term outcomes including the need for tube feeding or hospitalizations related to feeding/nutrition problems.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Cue-Based Vs. Clinician-Driven Feeding in Very Low Birthweight Infants: A Pilot Randomized Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 23, 2024
Registry last updated
Aug 15, 2025

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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