Study to Assess the Efficacy and Safety of NTRA-2112 on I... | NCT02510560

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NTRA-2112 A	Experimental	NTRA-2112 A - Dose 1 To be administered orally with daily feed for 28 days or until discharge from hospital.	Drug: NTRA-2112
NTRA-2112 B	Experimental	NTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital.	Drug: NTRA-2112
Placebo	Placebo Comparator	Placebo To be administered orally with daily feed for 28 days or until discharge from hospital.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
NTRA-2112	Drug		NTRA-2112 A NTRA-2112 B
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Numbers of Days to Achieve Complete Enteral Feeding	Numbers of days to achieve full enteral feeding (NFE) is defined as: Number of Days to the first day of achieving enteral feeding of at least 150 ml/kg/day, which must be sustained for at least 3 consecutive days.	28 days or discharge from hospital

Secondary Outcomes

Measure	Description	Time Frame
Number of Days to Achieve Discharge From Hospital or Readiness to Discharge	Readiness for discharge from hospital is defined as achieving all of the below: Infant weight ≥ 1800g Stable body temperature Capable of oral feeding (reached full enteral feeding and not dependent on PN)	28 days or discharge from hospital

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Vidant Medical Center		Greenville	North Carolina	27834	United States
University of Oklahoma Health Sciences Center

PubMed Identifier	Type	Citation	Retractions
35226099	Derived	Mank E, Saenz de Pipaon M, Lapillonne A, Carnielli VP, Senterre T, Shamir R, van Toledo L, van Goudoever JB; FIT-04 Study Group. Efficacy and Safety of Enteral Recombinant Human Insulin in Preterm Infants: A Randomized Clinical Trial. JAMA Pediatr. 2022 May 1;176(5):452-460. doi: 10.1001/jamapediatrics.2022.0020.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	NTRA-2112 A	NTRA-2112 A - Dose 1 To be administered orally with daily feed for 28 days or until discharge from hospital. NTRA-2112
FG001	NTRA-2112 B	NTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital. NTRA-2112

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 10, 2017	May 22, 2025

Arm/Group Information

ID	Title	Description
BG000	NTRA-2112 A	NTRA-2112 A - Dose 1 To be administered orally with daily feed for 28 days or until discharge from hospital. NTRA-2112
BG001	NTRA-2112 B	NTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital. NTRA-2112
BG002	Placebo	Placebo To be administered orally with daily feed for 28 days or until discharge from hospital. Placebo
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

26-28 weeks

Title	Measurements
	BG00049 BG00146 BG00251 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00064 BG00151 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Netherlands

Title	Measurements
	BG00025 BG00124 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Numbers of Days to Achieve Complete Enteral Feeding

Numbers of days to achieve full enteral feeding (NFE) is defined as:

Number of Days to the first day of achieving enteral feeding of at least 150 ml/kg/day, which must be sustained for at least 3 consecutive days.

Posted

Mean

Standard Deviation

Days

28 days or discharge from hospital

ID	Title	Description
OG000	NTRA-2112 A	NTRA-2112 A - Dose 1 To be administered orally with daily feed for 28 days or until discharge from hospital. NTRA-2112
OG001	NTRA-2112 B	NTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital. NTRA-2112
OG002	Placebo	Placebo To be administered orally with daily feed for 28 days or until discharge from hospital. Placebo

Units	Counts
Participants	OG00084 OG00178 OG00276

Title

Denominators

Categories

Title	Measurements
	OG0009.3± 4.81 OG00110.0± 6.09 OG00210.3± 5.10

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		Stratified Van Elteren Test		0.115														Superiority
OG001 OG002		Stratified Van Elteren Test		0.243

Secondary

Number of Days to Achieve Discharge From Hospital or Readiness to Discharge

Readiness for discharge from hospital is defined as achieving all of the below:

Infant weight ≥ 1800g
Stable body temperature
Capable of oral feeding (reached full enteral feeding and not dependent on PN)

Posted

Mean

Standard Deviation

Days

28 days or discharge from hospital

ID	Title	Description
OG000	NTRA-2112 A	NTRA-2112 A - Dose 1 To be administered orally with daily feed for 28 days or until discharge from hospital. NTRA-2112
OG001	NTRA-2112 B	NTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital. NTRA-2112
OG002	Placebo	Placebo To be administered orally with daily feed for 28 days or until discharge from hospital. Placebo

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	NTRA-2112 A	NTRA-2112 A - Dose 1 To be administered orally with daily feed for 28 days or until discharge from hospital. NTRA-2112	5	108	15	108	91	108
EG001	NTRA-2112 B	NTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital. NTRA-2112	1	88	10	88	70	88
EG002	Placebo	Placebo To be administered orally with daily feed for 28 days or until discharge from hospital. Placebo	4	97	19	97	81	97

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anaemia neonatal	Blood and lymphatic system disorders	Systematic Assessment	EG0000 affected108 at risk EG0010 affected88 at risk EG0021 affected97 at risk
Atrial thrombosis	Cardiac disorders	Systematic Assessment	EG0001 affected108 at risk EG0010 affected88 at risk EG0020 affected97 at risk
Cardiopulmonary failure	Cardiac disorders	Systematic Assessment	EG0001 affected108 at risk EG0010 affected88 at risk EG0020 affected97 at risk
Patent ductus arteriosus	Congenital, familial and genetic disorders	Systematic Assessment	EG0001 affected108 at risk EG0013 affected88 at risk EG0021 affected97 at risk
Cystic fibrosis	Congenital, familial and genetic disorders	Systematic Assessment	EG0001 affected108 at risk EG0010 affected88 at risk EG0020 affected97 at risk
Necrotising enterocolitis neonatal	Gastrointestinal disorders	Systematic Assessment	EG0007 affected108 at risk EG0013 affected88 at risk EG0028 affected97 at risk
Necrotising colitis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected108 at risk EG0011 affected88 at risk EG0023 affected97 at risk
Enterocolitis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected108 at risk EG0010 affected88 at risk EG0021 affected97 at risk
Haematochezia	Gastrointestinal disorders	Systematic Assessment	EG0000 affected108 at risk EG0010 affected88 at risk EG0021 affected97 at risk
Ileal stenosis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected108 at risk EG0010 affected88 at risk EG0021 affected97 at risk
Inguinal hernia	Gastrointestinal disorders	Systematic Assessment	EG0001 affected108 at risk EG0010 affected88 at risk EG0020 affected97 at risk
Intestinal perforation	Gastrointestinal disorders	Systematic Assessment	EG0000 affected108 at risk EG0011 affected88 at risk EG0020 affected97 at risk
Neonatal gastrointestinal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 affected108 at risk EG0010 affected88 at risk EG0020 affected97 at risk
Injury associated with device	General disorders	Systematic Assessment	EG0001 affected108 at risk EG0010 affected88 at risk EG0020 affected97 at risk
Multiple organ dysfunction syndrome	General disorders	Systematic Assessment	EG0000 affected108 at risk EG0010 affected88 at risk EG0021 affected97 at risk
Portal vein thrombosis	Hepatobiliary disorders	Systematic Assessment	EG0001 affected108 at risk EG0010 affected88 at risk EG0020 affected97 at risk
Sepsis neonatal	Infections and infestations	Systematic Assessment	EG0004 affected108 at risk EG0012 affected88 at risk EG0025 affected97 at risk
Neonatal pneumonia	Infections and infestations	Systematic Assessment	EG0000 affected108 at risk EG0010 affected88 at risk EG0022 affected97 at risk
Meningitis neonatal	Infections and infestations	Systematic Assessment	EG0000 affected108 at risk EG0010 affected88 at risk EG0021 affected97 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG0000 affected108 at risk EG0010 affected88 at risk EG0021 affected97 at risk
Systemic candida	Infections and infestations	Systematic Assessment	EG0001 affected108 at risk EG0010 affected88 at risk EG0020 affected97 at risk
subarachnoid haemorrhage	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected108 at risk EG0010 affected88 at risk EG0020 affected97 at risk
hyperglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected108 at risk EG0010 affected88 at risk EG0021 affected97 at risk
Hypoglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected108 at risk EG0011 affected88 at risk EG0020 affected97 at risk
Hypoglycaemia neonatal	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected108 at risk EG0011 affected88 at risk EG0020 affected97 at risk
Intraventricular haemorrhage neonatal	Nervous system disorders	Systematic Assessment	EG0000 affected108 at risk EG0010 affected88 at risk EG0021 affected97 at risk
Renal failure	Renal and urinary disorders	Systematic Assessment	EG0000 affected108 at risk EG0011 affected88 at risk EG0020 affected97 at risk
Neonatal respiratory acidosis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected108 at risk EG0011 affected88 at risk EG0021 affected97 at risk
Bronchopulmonary dysplasia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected108 at risk EG0010 affected88 at risk EG0020 affected97 at risk
Neonatal aspiration	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected108 at risk EG0010 affected88 at risk EG0020 affected97 at risk
Neonatal respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected108 at risk EG0010 affected88 at risk EG0020 affected97 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected108 at risk EG0010 affected88 at risk EG0020 affected97 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected108 at risk EG0010 affected88 at risk EG0020 affected97 at risk
patent ductus arteriosus repair	Surgical and medical procedures	Systematic Assessment	EG0001 affected108 at risk EG0011 affected88 at risk EG0020 affected97 at risk
Hypertension neonatal	Vascular disorders	Systematic Assessment	EG0000 affected108 at risk EG0010 affected88 at risk EG0021 affected97 at risk
Iliac vein occulsion	Vascular disorders	Systematic Assessment	EG0001 affected108 at risk EG0010 affected88 at risk EG0020 affected97 at risk
Neonatal hypotension	Vascular disorders	Systematic Assessment	EG0000 affected108 at risk EG0010 affected88 at risk EG0021 affected97 at risk
Shock haemorrhagic	Vascular disorders	Systematic Assessment	EG0001 affected108 at risk EG0010 affected88 at risk EG0020 affected97 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anaemia neonatal	Blood and lymphatic system disorders	Systematic Assessment	EG00039 affected108 at risk EG00134 affected88 at risk EG00234 affected97 at risk
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG00018 affected108 at risk EG00114 affected88 at risk EG00213 affected97 at risk
Bradycardia neonatal	Cardiac disorders	Systematic Assessment	EG0006 affected108 at risk EG0012 affected88 at risk EG0023 affected97 at risk
Neonatal tachycardia	Cardiac disorders	Systematic Assessment	EG0003 affected108 at risk EG0015 affected88 at risk EG0021 affected97 at risk
patent ductus arteriosis	Congenital, familial and genetic disorders	Systematic Assessment	EG00012 affected108 at risk EG0019 affected88 at risk EG0029 affected97 at risk
Necrotising enterocolitis neonatal	Gastrointestinal disorders	Systematic Assessment	EG0007 affected108 at risk EG0013 affected88 at risk EG0028 affected97 at risk
Gastroesophageal reflux disease	Gastrointestinal disorders	Systematic Assessment	EG0003 affected108 at risk EG0015 affected88 at risk EG0025 affected97 at risk
Sepsis neonatal	Infections and infestations	Systematic Assessment	EG0009 affected108 at risk EG0016 affected88 at risk EG0028 affected97 at risk
Ophthalmia neonatorum	Infections and infestations	Systematic Assessment	EG0004 affected108 at risk EG0016 affected88 at risk EG00210 affected97 at risk
Neonatal hyponatraemia	Metabolism and nutrition disorders	Systematic Assessment	EG00012 affected108 at risk EG0018 affected88 at risk EG0028 affected97 at risk
Hyperglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 affected108 at risk EG0012 affected88 at risk EG0026 affected97 at risk
Hypoglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 affected108 at risk EG0015 affected88 at risk EG0023 affected97 at risk
Intraventricular haemorrhage neonatal	Nervous system disorders	Systematic Assessment	EG0003 affected108 at risk EG0015 affected88 at risk EG0022 affected97 at risk
Jaundice neonatal	Pregnancy, puerperium and perinatal conditions	Systematic Assessment	EG0004 affected108 at risk EG0014 affected88 at risk EG0025 affected97 at risk
Infantile apnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00020 affected108 at risk EG00112 affected88 at risk EG00216 affected97 at risk
Bronchopulmonary dysplasia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0009 affected108 at risk EG0016 affected88 at risk EG0022 affected97 at risk
Neonatal respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0007 affected108 at risk EG0013 affected88 at risk EG0023 affected97 at risk
Neonatal hypoxia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0004 affected108 at risk EG0015 affected88 at risk EG0020 affected97 at risk

ID	Term
D047928	Premature Birth
D008286	Malabsorption Syndromes

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases