Cradle
Every Trial Begins
With One Question.
Cradle is a neonatal research center where specialists design clinical trials for infants born at the edge of viability — weighing less than a bag of flour. We carry the IRB infrastructure, the longitudinal data, and the Level IV NICU access. You bring the science.
"What gestational age range
does your cohort cover?"
Our cohort spans 23 to 40 weeks gestational age, with particular depth in the 24–28 week range — the critical window where most intervention trials are designed. Every patient is enrolled with longitudinal consent through 18 months corrected age.
Gestational Age Distribution
23 – 40 weeks
Total enrolled · Q4 2025
2,400
Median Birth Weight
Range: 385g – 2,100g. 34% of cohort born under 500g.
Sub-500g: 34% of cohort
Longitudinal Follow-up
Corrected age. Neurodevelopmental, pulmonary, and growth outcomes available.
Primary Diagnoses
Comorbidity Profile
Multi-diagnosis patients included in all categories
Respiratory
- BPD (38%)
- RDS (61%)
- Apnea (29%)
Cardiac
- PDA (44%)
- CHD (12%)
- Arrhythmia (7%)
Neurological
- IVH (23%)
- HIE (11%)
- NEC (8%)
Nutritional
- IUGR (31%)
- TPN dep. (56%)
- FGR (19%)
Questions researchers actually ask
before they sign the CTA.
We answer every operational question before asking for anything in return. Because the best research partnerships start with complete information.
Our full-board review completes in 14 calendar days for industry-sponsored trials. Expedited review for minimal-risk amendments averages 5 business days.
Full Board Review
14 days
Industry-sponsored
Expedited Review
5 days
Minimal-risk amendments
Protocol Amendments
48 hrs
Emergency safety changes
87% of our cohort completes the 18-month corrected age follow-up. Data includes Bayley-4 neurodevelopmental scores, pulmonary function, anthropometric growth, and re-hospitalization records.
All data de-identified per HIPAA Safe Harbor. Raw datasets available under executed DUA.
Our Level IV NICU operates 48 private isolette bays with integrated monitoring. Research-dedicated equipment includes high-frequency oscillatory ventilators, amplitude-integrated EEG, and near-infrared spectroscopy — all validated for sub-1kg patients.
HFOV Ventilators
8 units
Draeger VN500
aEEG Monitors
6 units
natus Olympic
NIRS Systems
4 units
Masimo O3
Isolette Bays
48 beds
Private, research-ready
Pharmacokinetic Lab
On-site
Micro-sampling
Biobank
-80°C
12,000 specimens
Yes. Our biorepository holds 12,000+ specimens from 1,800 patients: cord blood, serial plasma, urine, tracheal aspirates, and stool microbiome samples. Minimum volume: 50µL per aliquot.
We execute CDAs within 5 business days, CTAs within 30 days using our pre-negotiated template library. We support FFS, milestone-based, and grant-funded models. No IP restrictions on investigator-initiated trials.
"Can we access longitudinal
follow-up data at 18 months?"
Every trial we run publishes. Below are outcomes from our most recent partnerships — available in full via our capabilities deck.
Published Trials
Peer-reviewed outcomes since 2011
Patients Enrolled
Across all active and completed trials
Follow-up Retention
18-month corrected age completion
IRB Turnaround
Full-board review, industry-sponsored
Selected Publications
Surfactant Replacement in Periviable Neonates: A Phase III Multicenter Trial
Reduced BPD incidence by 31% in 23–25wk cohort
Prophylactic Indomethacin vs. Expectant Management for PDA Closure
NNT of 4 for surgical ligation avoidance
Amplitude-Integrated EEG Prediction of Neurodevelopmental Outcomes at 18 Months
AUC 0.88 for adverse neurodevelopment
Research Partners & Sponsor Networks
The question that changes
a life weighs less than a gram.
Every trial we run started with one conversation. Our clinical research coordinators are available for a 30-minute pre-consultation — no commitment, no paperwork, no IRB submission required to begin.
IRB Certified
FDA-registered, AAHRPP accredited
Level IV NICU
48 beds, private isolette bays
47 Published Trials
Since 2011, all outcomes available
Research Partnership Form
Step 1 of 3 — Your Role