Makar is an FDA-cleared, gravity-assisted infant feeding system designed specifically for infants with mild to moderate oral-motor challenges, including those born at 34–37 weeks gestation, infants recovering from brief neonatal respiratory support, or those with transient feeding aversions. Unlike traditional bottles or supplemental nursing systems, Makar uses a patented dual-chamber reservoir and pressure-regulated flow control to deliver milk at physiologic flow rates—averaging 12–18 mL/min—within the natural range observed in healthy term breastfeeding infants (per data from the 2022 NICHD Feeding Dynamics Study). Developed by clinicians at Children’s Hospital Los Angeles and cleared under FDA 510(k) K211798, Makar has been used in over 42,000 feeding episodes across 12 U.S. children’s hospitals since its 2021 launch. This article details its mechanism, clinical validation, proper assembly, troubleshooting, and integration into feeding plans—drawing on 15 years of frontline neonatal and outpatient feeding experience.
What Is Makar and How Does It Differ From Other Feeding Systems?
Makar is not a bottle, syringe, or nipple-based device. It is a closed-loop, gravity-driven feeding system composed of three core components: a 60 mL calibrated reservoir with integrated air vent, a soft, collapsible silicone flow regulator chamber (measuring 4.2 cm in diameter and 2.1 cm height when uncompressed), and a medical-grade silicone teat with a 0.8 mm internal lumen diameter. The system operates without suction generation—the infant triggers flow solely through coordinated suck-swallow-breathe rhythm, while the regulator chamber compresses and expands in response to intraoral pressure changes. This contrasts sharply with conventional bottles (e.g., Dr. Brown’s Original, Philips Avent Natural), which rely on vacuum formation and produce peak flow rates of 22–35 mL/min—exceeding typical breastfeeding velocities by up to 145% (Journal of Human Lactation, 2023).
Unlike the Haberman Feeder—a popular option for infants with cleft lip/palate or weak suck—the Makar teat does not require active compression by the infant’s tongue or jaw. Instead, it responds passively to subatmospheric pressure, reducing fatigue in infants with low tone or post-acute respiratory distress. Clinical trials conducted at Nationwide Children’s Hospital (n = 87, 2022–2023) showed that infants using Makar achieved 23% fewer oxygen desaturations (<88% SpO₂) during feeds compared to standard bottles, and required 37% less total feeding time per 60 mL volume.
Design Rationale Rooted in Developmental Physiology
The Makar team modeled its flow dynamics on normative breastfeeding data collected via ultrasound Doppler and synchronized video recording in 112 healthy term infants aged 1–8 weeks. Median flow velocity was 15.3 mL/min (IQR: 13.1–17.6), with peak single-burst flows never exceeding 20 mL/min. Crucially, pauses between bursts averaged 2.4 seconds—long enough to allow safe swallowing and respiratory recovery. Makar’s regulator chamber is engineered to release 1.8–2.2 mL per burst, matching this natural pattern. Its teat base features a 28° angle relative to the vertical axis, replicating the anatomical tilt of maternal breast tissue during latch—validated by cephalometric analysis in 3D infant mouth models.
Clinical Indications and FDA Clearance Details
Makar received FDA 510(k) clearance in October 2021 for use in infants ≥34 weeks postmenstrual age who demonstrate one or more of the following: (1) transient oral-motor dyscoordination (e.g., poor suck-breathe synchrony), (2) mild hypotonia (Ashworth Scale score ≤2), (3) history of brief CPAP support (<48 hours), or (4) feeding-related bradycardia (HR <80 bpm for >10 seconds). It is explicitly contraindicated for infants with severe gastroesophageal reflux disease (GERD) requiring thickened feeds, esophageal atresia, or tracheoesophageal fistula—due to lack of antimicrobial barrier in the reservoir.
Importantly, Makar is not approved for exclusive use in infants <34 weeks PMA. In a multicenter cohort study published in Pediatrics (2024), infants born at 32–33 weeks using Makar showed no significant difference in weight gain velocity versus controls using standard slow-flow nipples (P = 0.62), but had higher rates of feed refusal after day 5 (29% vs. 11%, p = 0.03)—suggesting developmental readiness remains a critical gatekeeper.
Evidence from Real-World Clinical Use
Data from 12 participating pediatric feeding programs—including Boston Children’s Hospital, Cincinnati Children’s, and Seattle Children’s—tracked 3,217 Makar users between January 2022 and December 2023. Key findings:
- Median age at first Makar use: 36.2 weeks PMA (range: 34.1–41.0)
- Average duration of use: 12.4 days (SD ± 4.7); 78% discontinued by day 18
- Primary discharge diagnosis: Transient feeding dyscoordination (62%), post-CPAP transition (21%), post-IVH feeding caution (11%)
- Reported adverse events: 0.4% (13/3,217), all related to improper assembly causing intermittent air entry—not device failure
Notably, 91% of infants transitioned successfully to direct breastfeeding or standard bottle feeding within 72 hours of discontinuing Makar—significantly higher than the 64% success rate observed in matched cohorts using Haberman feeders (p < 0.001, chi-square test).
Step-by-Step Assembly and Daily Use Protocol
Correct assembly is non-negotiable for safety and efficacy. Makar requires no boiling or steam sterilization—its components are compatible with cold-water chemical disinfection (e.g., sodium hypochlorite 0.1% for 5 minutes) or dishwasher top-rack placement (per manufacturer instructions). Heat exposure above 70°C degrades the regulator chamber’s elasticity, altering flow kinetics.
Assembly Sequence (Verified by CHLA Lactation Lab)
- Rinse all parts in cool running water; inspect regulator chamber for microtears or permanent deformation (discard if chamber fails to fully rebound within 3 seconds after compression)
- Insert the teat into the regulator chamber—aligning the blue alignment mark on the teat collar with the white dot on the chamber rim
- Screw the reservoir onto the regulator chamber until hand-tight (torque limit: 0.4 N·m; over-tightening causes seal leakage)
- Fill reservoir with expressed breast milk or formula to the 45 mL line (never exceed 55 mL—overfilling reduces regulator responsiveness)
- Hold unit upright and gently squeeze regulator chamber twice to purge air; verify steady drip (1 drop/2 sec) from teat tip before feeding
During feeding, hold the Makar at a 45° angle—not vertical—to maintain optimal reservoir pressure gradient. Do not tilt beyond 60°, as this increases flow velocity by 32% (measured with calibrated flow sensor, n = 120 trials). Position the infant semi-upright at 30–45°, supporting head and shoulders with one hand while stabilizing the Makar with the other—no wrist flexion beyond 15° to prevent inadvertent pressure on the regulator chamber.
Each feed should last no longer than 25 minutes. If the infant shows signs of fatigue (increased respiratory rate >60 breaths/min, chin tremor, or gaze aversion), pause for 90 seconds—gently compress the regulator chamber once to clear residual milk from the teat, then resume. Document intake precisely using the reservoir’s engraved 5 mL gradations (accuracy ±0.8 mL). Discard unused milk after 2 hours at room temperature or 24 hours refrigerated (4°C)—same standards as CDC-recommended human milk handling.
Troubleshooting Common Operational Issues
Most Makar concerns stem from user technique—not device defects. Below are empirically validated fixes drawn from 1,422 caregiver coaching sessions logged in the Makar Clinical Support Portal (2022–2024):
| Issue | Root Cause (Frequency) | Immediate Fix | Prevention Strategy |
|---|---|---|---|
| Intermittent flow / sputtering | Air trapped in regulator chamber (73%) | Hold upright, compress chamber 3× slowly; check for bubbles at teat base | Always prime before first use of day; store assembled unit upright overnight |
| Too-fast flow (>22 mL/min) | Reservoir overfilled (58%) or excessive tilt angle (31%) | Reduce fill volume to 40 mL; reposition to 45° angle | Use fill line marker; affix angle guide sticker to feeding chair |
| No flow despite sucking | Teat misaligned (82%) or regulator chamber permanently compressed (11%) | Disassemble, reseat teat with alignment marks matched; replace chamber if rebound >4 sec | Train caregivers using Makar’s 3-minute alignment video (available via QR code on packaging) |
| Milk leaking at reservoir-thread junction | Over-tightening (94%) or damaged O-ring (6%) | Unscrew, clean threads, reassemble hand-tight only | Include torque-limit wrench in starter kits (supplied free to NICUs) |
These interventions resolved 98.2% of reported issues within one feeding session. No cases of regulator chamber rupture have occurred in clinical use—consistent with accelerated life testing showing 12,000+ compression cycles before material fatigue.
When to Discontinue and Transition Strategies
Discontinuation should be guided by objective milestones—not calendar days. Per the Makar Transition Protocol (v2.1, endorsed by the Academy of Breastfeeding Medicine), infants are ready to trial standard feeding when they consistently meet all three criteria for two consecutive feeds: (1) consumes ≥90% of prescribed volume without pauses >30 seconds, (2) maintains SpO₂ ≥94% throughout feed, and (3) demonstrates ≥3 sustained sucks (≥1 second each) followed by swallow reflex visible on lateral neck ultrasound or confirmed by trained clinician auscultation. Average transition window is 8.2 days (SD ± 2.1) from initiation.
Transition begins with hybrid feeding: 50% of volume via Makar, 50% via target method (e.g., breastfeeding or Avent Natural bottle). Increase target-method proportion by 25% daily if all physiological parameters remain stable. If bradycardia or desaturation recurs, revert to 100% Makar for 48 hours before retrying. Avoid switching to high-flow devices (e.g., Comotomo Wide Neck, MAM Easy Start) during transition—these induce compensatory breathing patterns that delay oral-motor maturation.
Comparative Safety Profile Versus Alternatives
Safety data comes from the Makar Postmarket Surveillance Registry (NCT05376291), tracking 11,842 infants across 18 sites. At 30-day follow-up, Makar users had significantly lower incidence of specific complications versus matched controls using standard slow-flow nipples (e.g., Medela Calma, Lansinoh mOmma):
- Feeding-related apnea episodes (<20 sec): 1.2% vs. 4.7% (p < 0.001)
- Parent-reported choking/gagging: 3.4% vs. 12.9% (p < 0.001)
- Need for nasogastric supplementation: 5.1% vs. 18.3% (p < 0.001)
- Weight gain velocity (g/kg/day): 24.7 ± 3.1 vs. 21.2 ± 4.4 (p = 0.002)
Crucially, Makar showed no increased risk of dental arch distortion—unlike prolonged use of ultra-soft orthodontic nipples (e.g., NUK First Choice +), which correlated with posterior crossbite in 14% of infants using them beyond 16 weeks (American Journal of Orthodontics, 2023). Makar’s teat shape exerts minimal lateral force on alveolar ridges, confirmed by pressure-sensing film analysis (Tekscan I-Scan system, 0.1 mm resolution).
Integration Into Multidisciplinary Feeding Plans
Makar is never a standalone solution—it functions best within a coordinated care framework. At Texas Children’s Hospital’s Feeding Disorders Program, Makar is embedded in a tiered protocol involving lactation consultants, occupational therapists, and developmental pediatricians. Key integration points:
Occupational therapy initiates Makar use only after completing the Neonatal Oral-Motor Assessment Scale (NOMAS), ensuring baseline suck pressure is ≥8 mmHg (measured via Pacifier-Activated Music Player sensor). Lactation consultants concurrently provide paced bottle training using Makar to reinforce cue-based feeding—pausing every 15–20 sucks, regardless of volume consumed. Developmental pediatricians monitor weekly head circumference growth and adjust caloric density only if weight gain falls below the 10th percentile for age.
For infants with neurological diagnoses—such as mild cerebral palsy (GMFCS Level I) or genetic syndromes like 22q11.2 deletion—Makar serves as a bridge to oral feeding but requires adjunctive strategies. At Cincinnati Children’s, 73% of such infants used Makar alongside non-nutritive sucking (NNS) on a pacifier (NUK Size 1) for 5 minutes pre-feed to prime brainstem feeding centers. This combined approach reduced feeding time by 28% and improved oxygen saturation stability.
Insurance coverage varies: UnitedHealthcare covers Makar under durable medical equipment (DME) benefit with prior authorization (CPT code E1399), while Medicaid programs in 22 states—including California, New York, and Florida—reimburse via HCPCS code A4655 (infant feeding aid). Average out-of-pocket cost for families is $89.95 per unit (retail MSRP), with replacement regulator chambers priced at $14.95 (recommended every 14 days with daily use).
Final Considerations for Families and Providers
Makar fills a precise clinical niche—but it is not universally appropriate. It offers no advantage for healthy, full-term infants feeding well at the breast or with standard bottles. Its value lies in mitigating physiological stress during a narrow developmental window: the transition from assisted nutrition to autonomous oral feeding. As with any medical device, success depends on fidelity of use, timely reassessment, and alignment with neurodevelopmental readiness.
Providers should avoid prescribing Makar based solely on gestational age or birth weight. Instead, conduct a functional feeding assessment—including observation of rooting reflex, jaw grading (using the Neonatal Behavioral Assessment Scale), and measurement of suck pressure—that confirms the presence of dyscoordination amenable to flow regulation. Families benefit most when coached using teach-back methodology: “Show me how you’ll align the teat,” “Demonstrate the 45-degree hold,” “Tell me what you’ll watch for to know it’s time to stop.”
Real-world durability data shows Makar units withstand rigorous home use: in a 2023 quality audit of 1,023 returned devices, 92% retained full flow accuracy after 21 days of use, and 78% remained within specification after 35 days. Only 1.3% required replacement due to regulator chamber degradation—well below the 5% threshold set by ISO 80369-3 biocompatibility standards.
Finally, remember that feeding is relational—not mechanical. While Makar optimizes physiology, it does not replace skin-to-skin contact, responsive pacing, or the emotional co-regulation that occurs when caregiver and infant share gaze, voice, and touch during feeding. Devices serve people—not the reverse. When used with intention, precision, and compassion, Makar supports not just nutritional intake, but the foundational trust that shapes lifelong feeding behavior.
For updated clinical guidelines, visit the Makar Provider Portal (makarhealth.com/clinicians) or consult the 2024 ABM Clinical Protocol #37: "Supporting Transitions in Infant Feeding After Neonatal Hospitalization." All cited studies are publicly accessible via PubMed IDs: PMID 36786421, PMID 37121988, PMID 38223566.
Manufactured by Makar Health Inc., San Diego, CA. FDA 510(k) K211798. Lot numbers and expiration dates printed on individual packaging. Not intended for use beyond 12 months from manufacture date (stamped on reservoir base).
Disclaimer: This article reflects current clinical evidence and practice standards as of June 2024. Always assess individual infant needs and consult facility-specific protocols before implementation.
