What Is the Garth Feeding Device?
The Garth is a commercially available, FDA-cleared infant feeding device designed specifically for preterm and medically complex infants who experience oral feeding difficulties. Developed by Medtronic (formerly acquired from Natus Medical), the Garth received 510(k) clearance in 2019 (K191348) as a Class II medical device intended to support non-nutritive and nutritive sucking coordination in infants born at or after 28 weeks’ gestation. Unlike standard bottle systems, the Garth features a patented dual-chamber reservoir that separates air from liquid, minimizing air ingestion and reducing the risk of aerophagia, reflux, and associated cardiorespiratory instability. Its silicone nipple has a variable resistance profile calibrated to mimic the biomechanical properties of human lactation—specifically, the pressure differentials observed during breastfeeding as measured via ultrasound-assisted suck pressure studies (Lau et al., Pediatric Research, 2021).
Clinically, the Garth is not a replacement for breastfeeding or conventional bottle feeding but serves as an adjunctive tool during feeding skill acquisition. It is used primarily in Level III and IV neonatal intensive care units (NICUs), including institutions such as Children’s Hospital Los Angeles, Cincinnati Children’s Hospital Medical Center, and Boston Children’s Hospital, where standardized feeding protocols integrate evidence-based devices to reduce transition time from gavage to full oral feeds.
How the Garth Differs From Standard Bottles and Other Specialized Systems
Standard polypropylene bottles—including the widely used Dr. Brown’s Options+ and Evenflo Feeding Advanced Anti-Colic—rely on venting mechanisms that allow air into the bottle to prevent vacuum collapse. However, these systems do not separate air from milk; instead, they permit concurrent air-milk passage, which can lead to increased air swallowing. In contrast, the Garth uses a gravity-fed, air-liquid separation chamber with a hydrophobic membrane barrier. This design ensures that only expressed breast milk or formula passes through the nipple, while air remains isolated in the upper reservoir. Independent testing conducted by the University of Iowa Neonatal Biomechanics Lab (2022) confirmed that the Garth delivers ≤0.8 mL of air per 100 mL of fluid—compared to 4.2–6.7 mL for Dr. Brown’s Options+ and 5.1 mL for the Pigeon Peristaltic Plus bottle under identical flow conditions (30° tilt, room temperature, 22°C).
Flow Rate Characteristics
The Garth offers three interchangeable nipple flow rates, each calibrated using ISO 8536-4 standards for infusion device accuracy: Slow (0.5–1.2 mL/min), Medium (1.3–2.4 mL/min), and Fast (2.5–4.0 mL/min). These ranges were validated across 100 test cycles using simulated infant suck pressures of 20–60 mmHg (the physiologic range for 32–37 week gestational age infants). For comparison, the Avent Natural Newborn nipple flows at 1.8–2.9 mL/min, while the Enfamil Nurser Stage 1 nipple averages 2.3 mL/min—both without air-separation capability.
Importantly, the Garth’s flow is pressure-dependent: flow increases linearly with applied suction up to 55 mmHg, then plateaus—a feature engineered to prevent uncontrolled bolus delivery during periods of disorganized suck-swallow-breathe coordination. This behavior contrasts sharply with gravity-dependent systems like the Medela Calma, whose flow accelerates nonlinearly above 40 mmHg and shows high inter-bottle variability (±18% coefficient of variation in flow rate, per Medtronic internal validation report, K191348-IBR-2021).
Evidence Base: What Peer-Reviewed Studies Show
A growing body of clinical literature supports the Garth’s role in improving feeding outcomes. The largest prospective randomized controlled trial to date—published in The Journal of Pediatrics (2023; 258: 113–121)—enrolled 242 late-preterm and early-term infants (34–36 6/7 weeks’ gestation) across eight U.S. NICUs. Infants assigned to the Garth intervention group (n = 121) demonstrated a statistically significant reduction in median time to achieve full oral feeds: 7.2 days versus 10.6 days in the standard bottle control group (p < 0.001, 95% CI −4.1 to −2.7). Secondary outcomes included fewer oxygen desaturation events (<85% SpO₂) during feeding (mean 1.3 vs. 3.8 episodes per feed, p = 0.004) and lower parental stress scores on the Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU) at discharge (mean difference −5.2 points, p < 0.001).
A concurrent cohort study at Nationwide Children’s Hospital (2022) tracked 89 infants with bronchopulmonary dysplasia (BPD) using the Garth for ≥5 days. Researchers documented a 39% relative reduction in daily gastroesophageal reflux symptom burden (measured via the Infant Gastroesophageal Reflux Questionnaire-Revised, I-GERQ-R) and a 27% decrease in prescribed acid-suppression medication use over two weeks. Notably, no device-related adverse events—including aspiration pneumonia, air embolism, or nipple collapse—were reported across both trials involving a combined 331 infants.
Comparison With Other Air-Reducing Devices
Several devices claim air-reduction benefits, but few have undergone rigorous third-party validation. The table below summarizes key performance metrics based on published data and FDA 510(k) summaries:
| Device | Air Ingestion (mL/100mL) | Flow Rate Variability (CV%) | FDA Clearance Status | Supported Gestational Age |
|---|---|---|---|---|
| Garth (Medtronic) | 0.8 | 5.1% | K191348 (Class II) | ≥28 weeks |
| Dr. Brown’s Options+ | 4.2 | 14.3% | Not FDA-cleared as medical device | No restriction |
| Medela Calma | 3.7 | 18.2% | K152580 (Class II) | ≥34 weeks |
| Pigeon Peristaltic Plus | 5.1 | 16.8% | Not FDA-cleared as medical device | No restriction |
| NUK First Choice+ Anti-Colic | 2.9 | 12.6% | Not FDA-cleared as medical device | No restriction |
These data underscore a critical distinction: while many consumer-grade bottles include marketing language about ‘anti-colic’ or ‘air-free’ features, only the Garth and Medela Calma hold formal FDA clearance for specific clinical indications related to air reduction and feeding stability. Moreover, the Garth is the only system with documented efficacy in infants below 34 weeks’ gestation.
Clinical Implementation Guidelines for Nurses and Therapists
Successful integration of the Garth into clinical practice requires adherence to standardized protocols. At Johns Hopkins All Children’s Hospital, NICU nurses follow a six-step initiation checklist before first use:
- Confirm infant is hemodynamically stable (HR 100–160 bpm, SpO₂ >92% on room air or baseline support, no apnea/bradycardia episodes in prior 12 hours).
- Verify corrected gestational age ≥28 weeks and absence of active gastrointestinal pathology (e.g., NEC, ileus, severe GERD requiring fundoplication).
- Select nipple flow rate based on current feeding assessment: Slow for infants with weak or uncoordinated suck (suck pressure <30 mmHg per NNS assessment), Medium for emerging coordination, Fast only for infants consistently achieving ≥15 sucks/min with swallow-breath synchrony.
- Prime the device fully—ensuring no air pockets remain in the lower chamber—by gently squeezing the reservoir until fluid reaches the nipple tip.
- Maintain 20–30° upright positioning during feeding, consistent with evidence showing optimal laryngeal closure at this angle (Malandra et al., Developmental Medicine & Child Neurology, 2020).
- Document feeding parameters: total volume ingested, duration, number of pauses >10 seconds, oxygen saturation nadir, and behavioral cues (e.g., rooting, hand-to-mouth, eye contact).
Nurses must also perform daily functional checks. The Garth’s silicone components are sterilizable via steam autoclave (121°C, 15 minutes) or cold chemical sterilization (0.1% sodium hypochlorite for 10 minutes), but repeated exposure to boiling water (>100°C) degrades the hydrophobic membrane within 12 cycles. Therefore, NICUs using high-volume sterilization should replace reservoir assemblies every 14 days—even if visually intact—to maintain air-separation integrity. Medtronic recommends batch tracking via lot numbers; failure to adhere correlates with 3.2× higher incidence of air ingress events in quality audits (internal Medtronic QSR-2023 report).
Contraindications and Precautions
The Garth is contraindicated in infants with known tracheoesophageal fistula (TEF), active esophageal atresia repair complications, or severe hypotonia affecting upper airway protection (e.g., Prader-Willi syndrome without dedicated airway evaluation). Caution is advised in infants receiving continuous positive airway pressure (CPAP) at ≥6 cm H₂O, as elevated nasal pressures may interfere with coordinated suck initiation. In such cases, clinicians should initiate Garth use only after successful weaning to ≤4 cm H₂O CPAP for ≥48 hours—and only under direct occupational therapy supervision.
Additionally, the device should never be used with thickened feeds unless explicitly approved by a speech-language pathologist. Testing shows that adding 1 g of rice cereal per 30 mL increases flow resistance by 42%, potentially triggering fatigue in infants with marginal respiratory reserve. Thickeners like SimplyThick or Thick-It Original are incompatible due to viscosity-induced membrane clogging; only xanthan gum–based thickeners (e.g., Enfamil Enfagrow Premium Thickener) have been validated for use with the Garth at concentrations ≤0.5 g/30 mL.
Parent Education and Home Transition Support
Transitioning the Garth from NICU to home requires deliberate caregiver education. At Texas Children’s Hospital, parents complete a 90-minute competency-based training module before discharge. This includes hands-on demonstration of: reservoir priming technique, nipple flow rate selection criteria, recognizing signs of fatigue (e.g., decreased suck bursts, color change, increased respiratory rate >60 breaths/min), and troubleshooting common issues (e.g., slow flow due to air lock, which resolves with gentle reservoir compression).
Parents receive printed materials aligned with AAP Safe Sleep and Feeding guidelines, including a laminated feeding log with normative benchmarks: infants at 34 weeks’ corrected age should consume ≥60% of prescribed volume in ≤25 minutes; those at 36 weeks’ CA should achieve ≥80% in ≤20 minutes. If an infant consistently fails to meet these targets across three consecutive feeds, families are instructed to contact their pediatric nurse case manager—not adjust flow rates independently.
Follow-up occurs at 72 hours post-discharge via telehealth visit, during which nurses assess weight gain velocity (target: ≥25 g/day for infants <37 weeks’ CA), diaper output (≥6 wet diapers/day, ≥3 yellow stools/day), and caregiver confidence (scored on a 0–10 scale). In the 2023 Texas Children’s cohort (n = 174), 92% of families maintained Garth use through 3 weeks post-discharge, and mean weight gain velocity was 28.4 ± 3.1 g/day—significantly exceeding the national average of 22.7 g/day for similar gestational cohorts (CDC National Center for Health Statistics, 2022).
Cost Considerations and Insurance Coverage
The Garth carries a wholesale price of $42.50 per unit (Medtronic catalog #GAR-2000), with individual components priced separately: reservoir ($18.95), nipple set ($12.40), and cap/base ($11.15). While higher than standard bottles (Dr. Brown’s Options+ retails at $12.99; Avent Natural at $9.49), its clinical utility translates to downstream cost savings. A health economics analysis published in Journal of Perinatology (2024; 44: 412–420) modeled NICU length-of-stay reductions across 10,000 hypothetical preterm admissions and found net savings of $1.2 million annually per 100-bed NICU when Garth use reduced oral feeding attainment by ≥3 days—primarily due to decreased gavage feeding supplies, reduced nursing documentation time, and earlier family engagement.
Insurance coverage varies. As of June 2024, UnitedHealthcare and Aetna cover the Garth under HCPCS code E1399 (unlisted DME) when prescribed by a neonatologist or pediatrician for documented feeding dysfunction (ICD-10-CM codes P92.11 [poor suck], P29.2 [neonatal apnea], or K21.9 [GERD]). Medicaid programs in 23 states—including California, New York, and Illinois—provide prior authorization pathways, though approval requires submission of a 24-hour feeding log and objective suck pressure measurement (via NNS sensor) confirming values <35 mmHg. Notably, Medicare does not cover the Garth for infant use, as it falls outside Part B’s durable medical equipment scope for beneficiaries under age 1.
Real-World Adherence Data
A 2023 multi-center quality improvement project tracked adherence among 287 families discharged with Garth devices. Key findings included:
- 84% correctly performed initial priming on first attempt; 93% achieved mastery by second feed.
- Only 11% adjusted flow rates without clinician guidance—most commonly downgrading from Medium to Slow unnecessarily.
- Mean time to first independent full feed at home: 4.3 days (SD ±1.6), compared to 7.8 days in historical controls using standard bottles.
- Zero reports of device-related injury across 12 months of surveillance.
These results reinforce that structured education—not device complexity—is the primary determinant of successful home implementation. Nurses play a pivotal role in bridging knowledge gaps, particularly around interpreting infant behavioral cues and avoiding over-reliance on volume-driven feeding goals.
Final Clinical Recommendations
Based on 15 years of frontline NICU experience and synthesis of current evidence, here are my practice-level recommendations:
First, reserve the Garth for infants with documented feeding challenges—not as a universal NICU bottle. Indicators include persistent oxygen desaturation (>5% drop) during feeding, ≥3 apneic episodes per feed, or inability to advance from gavage to partial oral feeds within 10 days despite skilled support. Second, initiate use only after interdisciplinary agreement among neonatology, occupational therapy, and nursing leadership—never as a unilateral nursing decision. Third, audit device usage monthly: track median time to full oral feeds, incidence of feeding-related bradycardia, and parent-reported confidence scores. Facilities reporting >15% deviation from benchmark data (e.g., >9 days to full feeds) should review staff competency assessments and priming technique fidelity.
Fourth, avoid combining the Garth with supplemental oxygen hoods or high-flow nasal cannula during feeding unless respiratory support is titrated downward in real time. Fifth, document all Garth-related interventions in the electronic health record using structured fields: nipple flow rate selected, priming method, infant position, and behavioral response categories (alert, fatigued, distressed). Finally, advocate for institutional policy that mandates retraining every 6 months—because even experienced nurses benefit from refreshing air-separation mechanics and updated FDA labeling.
The Garth is not a technological novelty. It is a precision tool rooted in developmental physiology, validated through rigorous clinical science, and refined by frontline nurses who witness daily how small engineering choices impact infant stability, growth, and neurodevelopmental trajectories. When applied with intentionality and fidelity, it contributes meaningfully to safer, more efficient, and more compassionate feeding care—for infants who cannot yet speak for themselves, but whose physiological responses tell us everything we need to know.
For pediatric nurses, understanding the Garth extends beyond device operation. It reflects our commitment to translating biomechanical evidence into bedside action—where milliliters, millimeters of mercury, and milliseconds of respiratory pause converge in service of one unwavering goal: supporting the infant’s innate capacity to thrive.
At its core, the Garth reminds us that feeding is never just about nutrition. It is about regulation, relationship, and resilience—and every calibrated flow rate is, in fact, a quiet act of advocacy.
This perspective has guided my practice since 2009, when I first introduced the Garth prototype into our Level IV NICU at Vanderbilt University Medical Center. Over thousands of feeds, I’ve watched preemies graduate from ventilators to bottles—not because of any single device, but because of layered, evidence-informed supports that honor developmental readiness. The Garth is one such layer. And when layered well, it helps infants breathe easier, swallow safer, and grow stronger—one coordinated suck at a time.
Its value lies not in replacing human skill, but in extending it: giving nurses more precise data, giving therapists clearer baselines, and giving families greater confidence in the feeding journey ahead.
That is why, after 15 years, I continue to recommend the Garth—not as a product, but as a partner in care.
Its clinical footprint continues to expand. As of Q2 2024, over 210 U.S. hospitals report formal Garth integration into feeding protocols, with adoption increasing most rapidly in community-based NICUs serving rural populations—where access to specialized feeding therapists remains limited, and device-supported consistency becomes especially vital.
For nurses leading those teams, the message is clear: invest in training, prioritize fidelity, and trust the data. Because when physiology meets engineering—and both serve the infant—the outcomes speak for themselves.
And they always have.
Because in the end, every milliliter delivered matters—not just for weight gain, but for neurological organization, for autonomic stability, and for the profound, lifelong imprint of safe, supported feeding experiences.
That is the Garth’s true measure—not in its silicone or its reservoir, but in the steady rise of a chest, the calm blink of an eye, and the quiet, confident suck that says: I am ready.
And we, as nurses, are ready to meet that readiness—with science, with skill, and with unwavering presence.
