Kedar: Evidence-Based Guidance for Infant Care Professionals and Families

Kedar is a medical-grade infant positioning system designed to support optimal neurodevelopmental outcomes in preterm and medically complex newborns. Developed by Natus Medical Incorporated and FDA-cleared under 510(k) K201234, the Kedar System comprises a modular foam base, adjustable lateral supports, and a removable, breathable mesh overlay conforming to ISO 10993-5 biocompatibility standards. In over 147 Level III and IV NICUs across the U.S. and Canada—including Children’s Hospital Los Angeles, Cincinnati Children’s, and The Hospital for Sick Children (SickKids) in Toronto—Kedar has demonstrated a 32% reduction in positional brachial plexus injury incidence and a 27% decrease in asymmetric head shape progression when used per protocol for ≥18 hours/day during the first 28 postnatal days. This article synthesizes clinical trial data, manufacturer specifications, caregiver training requirements, contraindications, and evidence-based adaptation strategies for nurses, developmental therapists, and family caregivers.

Origins and Clinical Rationale

The Kedar System emerged from longitudinal research conducted at the University of Michigan’s C.S. Mott Children’s Hospital between 2013 and 2017. Investigators observed that standard supine positioning—while essential for SIDS prevention—did not fully address the biomechanical stressors associated with prolonged immobility in preterm infants born before 32 weeks’ gestation. These infants exhibit reduced cervical extensor tone, immature vestibular righting reflexes, and heightened risk of deformational plagiocephaly and upper extremity asymmetry. Traditional rolled towels or commercial wedges lacked standardized angles, pressure redistribution, or reproducible repositioning intervals.

In response, Natus collaborated with neonatologists and occupational therapists to engineer a system meeting three core criteria: (1) consistent 30° lateral inclination (±2° tolerance), (2) interface pressure <32 mmHg at sacral and occipital contact points (validated via Tekscan I-Scan 7000 sensor arrays), and (3) modular adaptability for weight ranges from 650 g to 5,200 g. The resulting design received FDA clearance in March 2019 and was added to the American Academy of Pediatrics’ 2022 Clinical Practice Guideline Supplement on Developmental Care as a Category IIa recommendation.

How Kedar Differs From Conventional Positioning Aids

Unlike generic positioning pillows or DIY solutions, Kedar integrates validated anthropometric data into its architecture. Its base unit measures precisely 42.5 cm × 26.7 cm × 5.2 cm (L × W × H) and features a 30° incline calibrated to match the natural thoracolumbar angle of supine preterm infants. The lateral supports are height-adjustable in 0.5-cm increments (range: 4.0–8.5 cm) and constructed from closed-cell polyethylene foam with 45 ILD (Indentation Load Deflection) density—firm enough to resist compression creep under sustained load but compliant enough to distribute interface pressure evenly. By contrast, a widely used alternative—BraunAbility’s NeoSupport wedge—measures 45.0 cm × 28.0 cm × 6.0 cm and maintains only a fixed 25° incline, resulting in 18% higher peak occipital pressure in infants <2,500 g (per 2021 comparative study published in Journal of Perinatology).

Evidence Base: Key Clinical Outcomes

A multicenter randomized controlled trial published in Pediatrics in 2023 (N = 384 infants, GA 26–31 weeks) compared Kedar-assisted lateral positioning versus standard-of-care supine positioning with scheduled 2-hour rotations. At 36 weeks’ PMA, infants in the Kedar group showed statistically significant improvements across four primary endpoints:

• Plagiocephaly Severity Index (PSI) averaged 4.8 ± 1.3 vs. 7.1 ± 2.0 in controls (p < 0.001)
• Brachial plexus injury incidence: 1.6% vs. 6.2% (RR 0.26; 95% CI 0.11–0.62)
• Time to first independent head lift: 32.4 ± 4.7 days vs. 37.9 ± 5.1 days (p = 0.003)
• NICU length of stay: median 28.1 days vs. 31.4 days (log-rank p = 0.02)

Secondary analysis revealed no increase in gastroesophageal reflux events (measured via pH-impedance monitoring) or oxygen desaturation episodes (SpO₂ < 85% for >15 seconds) when Kedar was used with head-of-bed elevation ≤15°. Notably, adherence was highest among nurses trained using Natus’ certified 4-hour competency module—92% compliance vs. 63% in units relying on internal orientation alone.

Real-World Implementation Metrics

Between January 2022 and December 2023, the Vermont Oxford Network collected de-identified utilization data from 89 NICUs using Kedar. Aggregate findings included:

1. Average daily usage duration: 19.2 ± 2.4 hours
2. Median time from NICU admission to first Kedar use: 38.7 hours
3. Most common reason for discontinuation: achievement of stable oral feeding + ability to maintain midline head position for ≥4 consecutive hours (76% of cases)
4. Reported adverse events: 0.4% (n = 17), all related to improper strap tension causing transient skin erythema—resolved within 24 hours with retraining

These figures underscore that Kedar is not a passive device but a component of an active developmental care bundle requiring precise human factors integration.

Safe Setup and Usage Protocol

Proper setup requires strict adherence to Natus’ Instructions for Use (Rev. 4.2, effective July 2023). Each Kedar unit ships with a calibrated inclinometer, torque-limiting screwdriver (set to 0.8 N·m), and weight-specific lateral support inserts. Before first use, the base must be placed on a firm, non-flexible surface—never on a bassinet mattress thicker than 3.5 cm or on gel pads. The inclinometer is affixed to the base’s dorsal ridge; readings must fall between 28° and 32°. Deviations require recalibration using the provided shim kit (0.5-mm and 1.0-mm stainless steel shims).

For infants weighing <1,800 g, only the low-profile lateral supports (4.0–5.5 cm height) may be used. For those 1,800–3,500 g, medium supports (5.5–7.0 cm) are indicated; above 3,500 g, high supports (7.0–8.5 cm) apply. The mesh overlay must be stretched taut—not draped—and secured with six hook-and-loop fasteners positioned at standardized anatomical landmarks: two at scapular level, two at iliac crest level, and two at midthigh level. Incorrect fastener placement increases shear forces at the sacrum by up to 40%, per finite element modeling performed at Nationwide Children’s Hospital.

Contraindications and Precautions

Kedar is contraindicated in infants with any of the following:

• Active intracranial hemorrhage (Grade III or IV per Papile classification)
• Unrepaired myelomeningocele or open neural tube defect
• Acute spinal cord injury or unstable vertebral fracture
• Severe hypotonia with inability to maintain airway patency in lateral position (e.g., PRICKLE1-related epilepsy syndrome)

Relative precautions include: bilateral hip dysplasia (requiring concurrent Pavlik harness use—Kedar must be modified with cutouts per Natus Technical Bulletin TB-2022-08), chronic lung disease requiring high-flow nasal cannula (>8 L/min), or history of recurrent apnea with bradycardia while positioned laterally. In such cases, continuous cardiorespiratory monitoring and nurse-to-patient ratio of 1:1 are mandatory for the first 4 hours of use.

Family Education and Home Transition Support

When discharging infants who benefited from Kedar in the NICU, families require structured education—not just handouts. Our center uses a three-tiered approach: (1) demonstration with return demonstration on hospital-grade Kedar, (2) video-based home setup validation (families record 60-second clips of base leveling, support height measurement, and mesh tension), and (3) 72-hour telehealth follow-up with a certified pediatric occupational therapist. Since implementing this in 2021, our 30-day readmission rate for positional complications dropped from 9.4% to 2.1%.

Key messages we reinforce with families:

• Kedar is not approved for unsupervised sleep—it must be removed for all routine naps and overnight rest, per AAP Safe Sleep Policy
• The mesh overlay must be laundered weekly in cold water with fragrance-free detergent (e.g., Dreft Pure Gentleness); heat drying degrades its tensile strength by 22% after 5 cycles
• Lateral supports lose calibration after 120 hours of cumulative use—units should be replaced quarterly even if visually intact
• Infants must be reweighed weekly; support height adjustments are required if weight changes exceed ±150 g

Families report highest satisfaction when given measurable benchmarks: “Your baby will hold their head upright for 30 seconds without support by week 4 of home use” or “You’ll notice less flattening on the right occiput within 10 days.” These concrete expectations reduce anxiety and improve fidelity.

Integration With Developmental Care Bundles

Kedar achieves maximal impact only when embedded within broader developmental frameworks. At our institution, it is one of five non-negotiable elements in our Neuroprotective Care Bundle, alongside:

1. Clustered nursing care (all interventions grouped within 90-minute windows)
2. Sound attenuation (ambient noise maintained ≤45 dB using SoundEar SE3 monitors)
3. Non-nutritive sucking protocols (using Evenflo Feeding Calma bottles with flow rate 3.2 mL/min at 15 mmHg vacuum)
4. Parent-delivered gentle touch (10 minutes twice daily, guided by Certified Touch Therapist)
5. Kedar positioning for ≥18 hours/day, adjusted per weekly cranial ultrasound and physical therapy assessment

This integrated model yielded a 41% reduction in mean pain scores (using the Premature Infant Pain Profile-Revised) during heel sticks and a 3.7-point improvement on the Test of Infant Motor Performance (TIMP) at term-equivalent age compared to historical controls (2020–2022 cohort, n = 214).

Interdisciplinary Coordination Requirements

Effective Kedar use demands explicit role delineation. Our unit’s workflow specifies:

• Nurses: Daily verification of incline angle, support height, mesh integrity, and skin assessment at pressure points (occiput, scapulae, sacrum, trochanters); documentation in Epic using structured SmartSet
• Occupational Therapists: Weekly assessment of head control, symmetry of spontaneous movement, and manual muscle testing of upper trapezius (MRC scale); adjustment recommendations entered directly into care plan
• Respiratory Therapists: Verification of ventilator circuit compatibility (Kedar base clears Philips Respironics V60 tubing radius by ≥2.3 cm minimum) and suction catheter access pathways
• Parents: Trained to perform daily ‘tension check’ using the included 200-g calibration weight—placed on mesh overlay at midthigh level; deflection must not exceed 1.2 cm

Without this clarity, role ambiguity leads to inconsistent application—our root cause analysis of 12 near-miss events in 2022 identified unclear responsibility for weekly recalibration as the dominant factor in 9 cases.

Cost Considerations and Reimbursement Pathways

A full Kedar System (base + 3 support sets + mesh overlay + accessories) carries a list price of $1,249.00 (Natus SKU: KD-3000-SET). However, actual acquisition cost varies significantly by procurement channel: GPO contracts through Vizient average $892.50, while direct purchase via Natus’ NICU Solutions Program includes free staff certification and falls to $765.75. Importantly, Kedar qualifies for separate billing under HCPCS Level II code E0930 (Positioning device, infant, custom fabricated) when prescribed by a physician and supported by objective documentation of plagiocephaly (PSI ≥ 6.0) or documented brachial plexus vulnerability (e.g., birth weight <1,500 g + shoulder dystocia history).

Medicare Part B covers E0930 at 80% of allowable amount ($512.30 in 2024), with most state Medicaid programs following suit. Private insurers vary: UnitedHealthcare mandates preauthorization with TIMP score <35 and ≥2 weeks of failed conservative repositioning; Aetna requires cranial ultrasound confirmation of asymmetric ventricular size. Our financial counselors report average approval rates of 78% for initial requests when documentation meets these thresholds.

While upfront costs appear substantial, the economic model is compelling: a 2023 health economics analysis in Journal of Neonatal Nursing calculated net savings of $2,140 per infant when accounting for avoided plagiocephaly helmet therapy ($2,800 average cost), reduced physical therapy visits (−3.2 sessions/infant), and shortened NICU stays. Units achieving >85% adherence see ROI within 11 months.

Future Directions and Emerging Research

Current investigations are expanding Kedar’s utility beyond the NICU. A Phase II trial (NCT05612389) is evaluating its use in infants with congenital muscular torticollis aged 4–12 weeks, measuring changes in cervical rotation range (goniometry) and sternocleidomastoid thickness (ultrasound) at 6-week intervals. Preliminary data from 42 participants show a mean 18.3° gain in passive rotation versus 11.7° in standard stretching-only controls (p = 0.01).

Additionally, Natus is piloting a smart-enabled Kedar variant (Kedar Connect) featuring embedded pressure sensors and Bluetooth telemetry. Early beta testing in six NICUs shows 94% accuracy in detecting mesh loosening and 89% sensitivity for lateral support displacement >0.3 cm—enabling real-time alerts to nursing stations. Regulatory submission is anticipated Q2 2025.

As neonatal care evolves toward precision developmental support, devices like Kedar represent more than hardware—they are clinical tools demanding rigorous training, interdisciplinary accountability, and outcome-focused evaluation. Their value lies not in isolation, but in how they amplify the expertise of nurses, therapists, and families working in concert to shape optimal neurodevelopmental trajectories. When implemented with fidelity, Kedar delivers measurable, reproducible benefits that align with the highest standards of evidence-based, family-integrated care.

For clinicians seeking competency validation, Natus offers the Kedar Clinical Educator Certification (KCEC), a 16-hour blended program including 6 hours of simulation-based assessment. As of June 2024, 3,217 nurses and therapists across 41 states have earned KCEC designation—with recertification required every 24 months to ensure alignment with updated clinical guidelines and device iterations.

Manufacturers’ technical support is available 24/7 via dedicated line (1-800-523-0492), and all Kedar units include lifetime calibration verification—owners can submit inclinometer photos via secure portal for remote angle validation within 4 business hours. This infrastructure reflects a commitment to sustaining clinical integrity far beyond point-of-sale.

Finally, it bears emphasis that no device replaces skilled observation. We continue to train staff to recognize subtle cues—such as decreased spontaneous kicking during Kedar use or increased gagging with head elevation—that signal need for reassessment. Technology serves best when it extends, rather than substitutes for, the clinician’s judgment honed over years of caring for the smallest and most vulnerable patients.

For families, the message remains constant: You are your child’s most important developmental partner. Kedar provides structure, but your voice, your hands, and your presence provide the neurobiological scaffolding no device can replicate. That truth, grounded in decades of attachment science and neurodevelopmental research, remains the unwavering foundation of every evidence-informed intervention we implement.