Apply to Trial

Compensation: Varies

Number of Visits: 1

Duration: Until NICU discharge

74 Participants Needed

Cue-Based Feeding for Low Birth Weight Infants

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Congenital anomalies, Cardiovascular symptoms, Necrotizing enterocolitis

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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 Cue-Based Feedings for Low Birth Weight Infants?

Research shows that cue-based feeding, which involves feeding infants based on their readiness signals, can lead to earlier achievement of full oral feeding, improve short-term health outcomes, and enhance parents' involvement in the feeding process for preterm infants.¹ ² ³ ⁴ ⁵

Is cue-based feeding safe for low birth weight infants?

The research on cue-based feeding for preterm infants suggests it is generally safe, as it focuses on feeding based on infants' readiness and cues, which can improve feeding outcomes and parent involvement without reported safety concerns.² ³ ⁴ ⁵ ⁶

How is the treatment Cue-Based Feedings different from other treatments for low birth weight infants?

Cue-Based Feeding is unique because it focuses on feeding preterm infants based on their behavioral cues, such as signs of hunger and readiness to eat, rather than on a fixed schedule. This approach can improve feeding outcomes, enhance parent involvement, and potentially lead to earlier hospital discharge compared to traditional scheduled feeding methods.² ³ ⁴ ⁵ ⁶

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for very low birthweight infants who weigh less than 1500 grams, are between 28 and 31 weeks old gestationally, have full enteral feeding established before turning 32 weeks postmenstrual age (PMA), and start oral feeding before reaching 33 weeks PMA.

Inclusion Criteria

My baby was born weighing less than 1500 grams, between 28-31 weeks, and started full and oral feeding early.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Infants are assigned to either cue-based or clinician-driven feeding plans

Until NICU discharge

Follow-up

A follow-up phone call 3 months after NICU discharge to assess long-term outcomes

3 months

1 phone call

Treatment Details

Interventions

Cue-Based Feedings

Trial Overview The study compares two methods of feeding in these infants: cue-based feedings led by speech therapists and nurses trained to recognize infant cues versus clinician-driven feedings where clinicians decide the feeding plan based on daily assessments.

Participant Groups

2Treatment groups

Active Control

Group I: ControlActive Control1 Intervention

Clinician based feedings

Group II: InterventionActive Control1 Intervention

Cue-based feedings

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

A cue-based clinical pathway for managing oral feedings in premature infants led to them achieving full oral feeding 6 days earlier than those managed by traditional physician orders, with a significant difference in postmenstrual age (PMA) at the time of achievement (P=0.02).

The study involved 51 preterm infants (28 in the cue-based group and 23 in the control group), and there were no significant differences in gender, gestational age, birth weight, or ventilator days between the two groups, indicating that the results were likely due to the feeding management approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cue-based oral feeding clinical pathway results in earlier attainment of full oral feeding in premature infants.Kirk, AT., Alder, SC., King, JD.[2007]

Implementing cue-based feeding for preterm infants significantly reduced the time to achieve full oral feedings by an average of 7 days for the youngest infants and 6.6 days for slightly older infants, indicating improved feeding efficiency.

The intervention also decreased the length of hospital stays by 4.4 days for the youngest infants and 2.7 days for older infants, while increasing parental involvement in feeding by 80% and 49%, respectively, leading to substantial cost savings for the hospital.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of Cue-Based Feeding to Improve Preterm Infant Feeding Outcomes and Promote Parents' Involvement.Thomas, T., Goodman, R., Jacob, A., et al.[2021]

Responsive feeding in preterm infants, which involves feeding based on hunger cues rather than scheduled intervals, may lead to slightly slower weight gain but helps infants transition to full oral feeding more quickly, reducing the time from tube to oral feeding by about 5.5 days.

The evidence regarding the overall impact of responsive feeding on important outcomes like growth rates and hospital stay duration is weak and inconsistent, indicating a need for larger, more rigorous studies to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responsive versus scheduled feeding for preterm infants.Watson, J., McGuire, W.[2018]