Trial Outcomes & Findings for A Safety and Efficacy Study of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age (NCT NCT04264156)

Last Updated: 2023-05-24

Results Overview

Number of participants with respiratory failure due to RDS or death. Respiratory failure due to RDS is defined as intubation for mechanical ventilation and/or surfactant administration

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

28 days of life

Results posted on

2023-05-24

Participant Flow

Enrollment period: 18 April 2020 to 19 January 2021 Enrollment occurred in neonatal intensive care units.

Subjects were screened before enrollment. Screen fail reasons included: unable to maintain required FiO2 (majority of screen fails), no determination of RDS, need for mechanical ventilation, outside of enrollment window

Participant milestones

Participant milestones
Measure	Lucinactant (160 mg/kg) + nCPAP Lucinactant for inhalation, 160 mg total phospholipids (TPL)/kg Delivered as an aerosol, with up to 3 repeats of 80 mg/kg allowed within 36 hours of birth Lucinactant for Inhalation: A drug-device combination product that delivers aerosolized SRT to preterm neonates with RDS who are being supported with nCPAP.	nCPAP Only nCPAP Only as sham comparator. Bubble nCPAP is standard of care. Treatment time behind barrier to match active treatment delivery time nCPAP Only: Nasal CPAP Alone
Overall Study STARTED	11	1
Overall Study COMPLETED	11	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Safety and Efficacy Study of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 28 days of life

Population: Intent-to-Treat

Number of participants with respiratory failure due to RDS or death. Respiratory failure due to RDS is defined as intubation for mechanical ventilation and/or surfactant administration

Outcome measures

Outcome measures
Measure	Lucinactant (160 mg/kg) + nCPAP n=11 Participants Lucinactant for inhalation, 160 mg total phospholipids (TPL)/kg Delivered as an aerosol, with up to 3 repeats of 80 mg/kg allowed within 36 hours of birth Lucinactant for Inhalation: A drug-device combination product that delivers aerosolized SRT to preterm neonates with RDS who are being supported with nCPAP.	nCPAP Only n=1 Participants nCPAP Only as sham comparator. Bubble nCPAP is standard of care. Treatment time behind barrier to match active treatment delivery time nCPAP Only: Nasal CPAP Alone
Number of Participants With Respiratory Failure or Death	6 Participants	0 Participants

SECONDARY outcome

Timeframe: 36 weeks post-menstrual age (PMA)

Population: Intent-to-Treat

Number of participants with bronchopulmonary dysplasia (BPD)

Outcome measures

Outcome measures
Measure	Lucinactant (160 mg/kg) + nCPAP n=11 Participants Lucinactant for inhalation, 160 mg total phospholipids (TPL)/kg Delivered as an aerosol, with up to 3 repeats of 80 mg/kg allowed within 36 hours of birth Lucinactant for Inhalation: A drug-device combination product that delivers aerosolized SRT to preterm neonates with RDS who are being supported with nCPAP.	nCPAP Only n=1 Participants nCPAP Only as sham comparator. Bubble nCPAP is standard of care. Treatment time behind barrier to match active treatment delivery time nCPAP Only: Nasal CPAP Alone
Number With BPD	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 36 weeks PMA or 28 days of life (whichever is later)

Population: Intent-to-Treat

All-cause mortality

Outcome measures

Outcome measures
Measure	Lucinactant (160 mg/kg) + nCPAP n=11 Participants Lucinactant for inhalation, 160 mg total phospholipids (TPL)/kg Delivered as an aerosol, with up to 3 repeats of 80 mg/kg allowed within 36 hours of birth Lucinactant for Inhalation: A drug-device combination product that delivers aerosolized SRT to preterm neonates with RDS who are being supported with nCPAP.	nCPAP Only n=1 Participants nCPAP Only as sham comparator. Bubble nCPAP is standard of care. Treatment time behind barrier to match active treatment delivery time nCPAP Only: Nasal CPAP Alone
Mortality	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 36 weeks PMA

Population: Intent-to-Treat

Number of participants with complications including intraventricular hemorrhage, periventricular leukomalacia, pulmonary hemorrhage, apnea, necrotizing enterocolitis, patent ductus arteriosus, acquired sepsis, and retinopathy of prematurity.

Outcome measures

Outcome measures
Measure	Lucinactant (160 mg/kg) + nCPAP n=11 Participants Lucinactant for inhalation, 160 mg total phospholipids (TPL)/kg Delivered as an aerosol, with up to 3 repeats of 80 mg/kg allowed within 36 hours of birth Lucinactant for Inhalation: A drug-device combination product that delivers aerosolized SRT to preterm neonates with RDS who are being supported with nCPAP.	nCPAP Only n=1 Participants nCPAP Only as sham comparator. Bubble nCPAP is standard of care. Treatment time behind barrier to match active treatment delivery time nCPAP Only: Nasal CPAP Alone
Number of Participants With Common Complications of Prematurity	9 Participants	1 Participants

Adverse Events

Lucinactant (160 mg/kg) + nCPAP

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

nCPAP Only

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lucinactant (160 mg/kg) + nCPAP n=11 participants at risk Lucinactant for inhalation, 160 mg total phospholipids (TPL)/kg Delivered as an aerosol, with up to 3 repeats of 80 mg/kg allowed within 36 hours of birth Lucinactant for Inhalation: A drug-device combination product that delivers aerosolized SRT to preterm neonates with RDS who are being supported with nCPAP.	nCPAP Only n=1 participants at risk nCPAP Only as sham comparator. Bubble nCPAP is standard of care. Treatment time behind barrier to match active treatment delivery time nCPAP Only: Nasal CPAP Alone
Congenital, familial and genetic disorders Duodenal atresia	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Respiratory, thoracic and mediastinal disorders Pneumonediastinum	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Respiratory, thoracic and mediastinal disorders Pneumothorax	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.

Other adverse events

Additional Information

Executive Director of Biostatistics & Data Management

Windtree Therapeutics, Inc.

Phone: 2154889300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The preparation and submittal for publication of a manuscript containing the study results shall be in accordance with a process determined by a mutual written agreement among Windtree and participating institutions. The publication or presentation of any study results shall comply with all applicable privacy laws, including but not limited to HIPAA.
Publication restrictions are in place

Restriction type: OTHER

Measure	Lucinactant (160 mg/kg) + nCPAP n=11 Participants Lucinactant for inhalation, 160 mg total phospholipids (TPL)/kg Delivered as an aerosol, with up to 3 repeats of 80 mg/kg allowed within 36 hours of birth Lucinactant for Inhalation: A drug-device combination product that delivers aerosolized SRT to preterm neonates with RDS who are being supported with nCPAP.	nCPAP Only n=1 Participants nCPAP Only as sham comparator. Bubble nCPAP is standard of care. Treatment time behind barrier to match active treatment delivery time nCPAP Only: Nasal CPAP Alone	Total n=12 Participants Total of all reporting groups
Age, Continuous	3.25 hours n=5 Participants	1.05 hours n=7 Participants	3.02 hours n=5 Participants
Age, Customized Gestational Age	30.3 weeks n=5 Participants	31.0 weeks n=7 Participants	30.4 weeks n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	0 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	1 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	1 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Poland	11 participants n=5 Participants	1 participants n=7 Participants	12 participants n=5 Participants
Apgar Score at One Minute	7.0 Scores on a scale n=5 Participants	7.0 Scores on a scale n=7 Participants	7.0 Scores on a scale n=5 Participants
Apgar Score at Five Minutes	8.0 Scores on a scale n=5 Participants	8.0 Scores on a scale n=7 Participants	8.0 Scores on a scale n=5 Participants

Measure	Lucinactant (160 mg/kg) + nCPAP n=11 participants at risk Lucinactant for inhalation, 160 mg total phospholipids (TPL)/kg Delivered as an aerosol, with up to 3 repeats of 80 mg/kg allowed within 36 hours of birth Lucinactant for Inhalation: A drug-device combination product that delivers aerosolized SRT to preterm neonates with RDS who are being supported with nCPAP.	nCPAP Only n=1 participants at risk nCPAP Only as sham comparator. Bubble nCPAP is standard of care. Treatment time behind barrier to match active treatment delivery time nCPAP Only: Nasal CPAP Alone
Blood and lymphatic system disorders Anemia neonatal	72.7% 8/11 • Number of events 9 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Blood and lymphatic system disorders Coagulation disorder neonatal	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Blood and lymphatic system disorders Leukocytosis	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Blood and lymphatic system disorders Neutropenia	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Cardiac disorders Tachycardia	18.2% 2/11 • Number of events 2 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Congenital, familial and genetic disorders Congenital pneumonia	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Congenital, familial and genetic disorders Duodenal atresia	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Congenital, familial and genetic disorders Patent ductus arteriosus	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Gastrointestinal disorders Abdominal distension	27.3% 3/11 • Number of events 3 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Gastrointestinal disorders Haematochezia	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Gastrointestinal disorders Necrotizing enterocolitis neonatal	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Gastrointestinal disorders Regurgitation	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	100.0% 1/1 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Gastrointestinal disorders Umbilical hernia	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
General disorders Oedema	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Hepatobiliary disorders Cholestasis	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Infections and infestations Conjunctivitis	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Infections and infestations Sepsis neonatal	27.3% 3/11 • Number of events 3 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	100.0% 1/1 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Injury, poisoning and procedural complications Infusion site extravasation	18.2% 2/11 • Number of events 4 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Investigations Body temperature increased	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Investigations Gastric residual assessment	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Investigations Oxygen saturation decreased	63.6% 7/11 • Number of events 8 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	100.0% 1/1 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Metabolism and nutrition disorders Feeding intolerance	36.4% 4/11 • Number of events 4 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	100.0% 1/1 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Metabolism and nutrition disorders Hyperglycaemia	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Metabolism and nutrition disorders Hyponatraemia	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Metabolism and nutrition disorders Hypovolaemia	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Metabolism and nutrition disorders Metabolic acidosis	18.2% 2/11 • Number of events 2 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Metabolism and nutrition disorders Osteopenia	18.2% 2/11 • Number of events 2 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Nervous system disorders Tremor	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Pregnancy, puerperium and perinatal conditions Agitation neonatal	45.5% 5/11 • Number of events 6 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	100.0% 1/1 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Pregnancy, puerperium and perinatal conditions Bradycardia neonatal	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Pregnancy, puerperium and perinatal conditions Intraventricular haemorrhage neonatal	54.5% 6/11 • Number of events 6 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Pregnancy, puerperium and perinatal conditions Jaundice neonatal	63.6% 7/11 • Number of events 8 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Pregnancy, puerperium and perinatal conditions Neonatal respiratory distress syndrome	27.3% 3/11 • Number of events 3 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Renal and urinary disorders Oliguria	0.00% 0/11 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	100.0% 1/1 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	100.0% 1/1 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Respiratory, thoracic and mediastinal disorders Hypercapnia	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Respiratory, thoracic and mediastinal disorders Infantile apnoea	72.7% 8/11 • Number of events 13 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Respiratory, thoracic and mediastinal disorders Nasal inflammation	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	100.0% 1/1 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Respiratory, thoracic and mediastinal disorders Neonatal aspiration	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Respiratory, thoracic and mediastinal disorders Nasal septum ulceration	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Respiratory, thoracic and mediastinal disorders Neonatal tachypnoea	27.3% 3/11 • Number of events 3 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Skin and subcutaneous tissue disorders Erythema	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Skin and subcutaneous tissue disorders Skin irritation	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Skin and subcutaneous tissue disorders Umbilical erythema	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Surgical and medical procedures Haemostatsis	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Vascular disorders Cardiovascular disorder	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Vascular disorders Haemangioma	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Vascular disorders Hypotension	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Vascular disorders Peripheral vascular disorder	9.1% 1/11 • Number of events 1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.
Vascular disorders Poor peripheral circulation	18.2% 2/11 • Number of events 2 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.	0.00% 0/1 • Through 36 weeks PMA or discharge/transfer, an average of 28 days of life.