Cue-Based Feeding for Low Birth Weight Infants

Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to feed very low birthweight infants, defined as babies born weighing less than 1500 grams. The study compares two methods: cue-based feeding, where trained professionals decide when the baby should eat based on the baby's signals, and the usual method, where the doctor sets the schedule. The researchers aim to determine if cue-based feeding improves infant growth or development. Babies born between 28 and 31 weeks who have started feeding by mouth before 33 weeks might be suitable candidates. As an unphased study, this trial offers a unique opportunity to contribute to innovative research that could enhance feeding practices for vulnerable infants.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What prior data suggests that cue-based feeding is safe for low birth weight infants?

Research has shown that cue-based feeding is generally safe for babies with low birth weight. In studies, babies weighing less than 1,500 grams experienced fewer breathing problems when fed based on their cues. Cue-based feeding involves caregivers watching for signs that a baby is ready to eat, rather than adhering to a strict schedule. This method ensures that babies are fed in a way that meets their individual needs. Overall, cue-based feeding is well-tolerated and recommended for its positive effects on the health of premature babies.12345

Why are researchers excited about this trial?

Unlike traditional clinician-based feedings for low birth weight infants, cue-based feeding focuses on the infant's natural feeding cues, such as rooting or sucking motions, rather than a strict schedule. Researchers are excited about this method because it can promote more personalized and responsive care, potentially leading to improved growth and developmental outcomes for these vulnerable infants. By aligning feeding times with the infant's readiness, cue-based feedings might also reduce stress for both infants and caregivers, creating a more nurturing and effective feeding experience.

What evidence suggests that cue-based feeding is effective for low birth weight infants?

Research shows that cue-based feeding, the focus of this trial, works well for very low birth weight babies. Studies have found that babies using this method start eating on their own faster than with other methods. Specifically, they begin full oral feeding about 3 days sooner and leave the hospital around 11 days earlier. Cue-based feeding also leads to better short-term health, such as more weight gain and less need for oxygen. These findings suggest that cue-based feeding could improve infant health in the NICU.25678

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: ControlActive Control1 Intervention
Group II: InterventionActive Control1 Intervention

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+

Published Research Related to This Trial

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.
Implementation of Cue-Based Feeding to Improve Preterm Infant Feeding Outcomes and Promote Parents' Involvement.Thomas, T., Goodman, R., Jacob, A., et al.[2021]
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.
Cue-based oral feeding clinical pathway results in earlier attainment of full oral feeding in premature infants.Kirk, AT., Alder, SC., King, JD.[2007]
A systematic review of nine randomized controlled trials involving 593 preterm infants found that responsive feeding, based on hunger cues, may lead to slightly slower weight gain compared to scheduled feeding, with a mean difference of -1.36 g/kg/day.
There is low-quality evidence suggesting that responsive feeding could help preterm infants transition to full oral feeding about 5.5 days earlier than those fed at scheduled intervals, but the overall impact on hospital discharge duration remains uncertain.
Responsive versus scheduled feeding for preterm infants.Watson, J., McGuire, W.[2021]

Citations

Cue-based feeding and short-term health outcomes of ...The findings indicate that cue-based feeding is beneficial for preterm infants. Therefore, it is recommended that nurses employ cue-based feeding in the NICU.
Cue-based feeding in the NICU—a pathway to earlier oral ...Cue-based feeding results in faster transition to full oral feeding in very low birth weight preterm infants and at an earlier gestational age.
Effect of cue-based feeding on time to nipple ...Cue-based feeding has shown to have positive effects on short-term health outcomes in infants, demonstrating greater weight gain, fewer oxygen ...
Effect of Cue‐Based Feeding on the Feeding Outcomes ...The results indicated that CBF was effective in shortening the time to achieve full oral feeding (Z = 22.32, p < 0.01) and reducing the ...
Effectiveness of Cue-Based Feeding Versus Scheduled ...The cue-based feeding group achieved full oral feeding on average 3.13 days sooner (3.55 ± 1.24 vs 6.68 ± 2.00) and infants were discharged on average 11.55 ...
Cue-based feeding in the NICU—a pathway to earlier oral ...Infants with a birth weight <1,500 g were less likely to experience adverse respiratory episodes during cue-based feeding. Although the rate of ...
Cue-based feeding and short-term health outcomes of ...The findings indicate that cue-based feeding is beneficial for preterm infants. Therefore, it is recommended that nurses employ cue-based feeding in the NICU.
Cue-Based Feeding for Low Birth Weight InfantsThe 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 ...
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