Clinical Trials Register

Summary
EudraCT Number:	2011-002919-28
Sponsor's Protocol Code Number:	CORTLATE
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2011-12-05
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-002919-28

A.3

Full title of the trial

Antenatal corticosteroids and respiratory distress syndrome in late preterm infants born by elective cesarean section. Multicentric randomized controlled clinical trial

CORTICOSTEROIDI PRENATALI ED INCIDENZA DI PATOLOGIA RESPIRATORIA NEI NEONATI LATE PRETERM DA TAGLIO CESAREO ELETTIVO. STUDIO CLINICO RANDOMIZZATO CONTROLLATO MULTICENTRICO

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Evaluation of the dicrease of respiratory distress syndrome in newborn infants 34-36 weeks of g.a. born by elective cesarean section after antenatal corticosteroids prophylaxis.

Valutazione della riduzione della malattia respiratoria nei neonati con eta' gestazionale 34-36 settimane nati da taglio cesareo elettivo da madre trattata con corticosteroidi nel periodo preparto.

A.3.2

Name or abbreviated title of the trial where available

CORTLATE

A.4.1

Sponsor's protocol code number

CORTLATE

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	U.O. Neonatoogia e TIN- Fondazione IRCCS "Ca' Granda" Ospedale Maggiore Policlinico
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fondazione IRCCS "Ca' Granda" Ospedale Maggiore Policlinico
B.5.2	Functional name of contact point	U.O. Neonatoogia e TIN
B.5.3	Address:
B.5.3.1	Street Address	Via della Commenda, 12
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20122
B.5.3.4	Country	Italy
B.5.4	Telephone number	02-55032234
B.5.5	Fax number	02-55032217
B.5.6	E-mail	gloria.cristofori@mangiagalli.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	CELESTONE*IM IV 5F 4MG/ML 1ML
D.2.1.1.2	Name of the Marketing Authorisation holder	SCHERING PLOUGH SpA
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BETAMETHASONE SODIUM PHOSPHATE
D.3.9.1	CAS number	151-73-5
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Corticosteroide

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Prophylaxis of respiratory distress syndrome in late preterm infants (34-36 weeks of gestational age)with antenatal corticosteroids

Prevenzione del distress respiratorio nel neonato prematuro 34-36 settimane di gestazione con corticosteroidi prenatali

E.1.1.1

Medical condition in easily understood language

Prophylaxis of respiratory distress syndrome in late preterm infants (34-36 weeks of gestational age)with antenatal corticosteroids

Prevenzione del distress respiratorio nel neonato prematuro 34-36 settimane di gestazione con corticosteroidi prenatali

E.1.1.2

Therapeutic area

Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.0
E.1.2	Level	HLGT
E.1.2	Classification code	10028920
E.1.2	Term	Neonatal and perinatal conditions
E.1.2	System Organ Class	10036585 - Pregnancy, puerperium and perinatal conditions

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To compare the incidence of RDS which requires any ventilatory support (nCPAP, SIPAP, mechanical ventilation, INSURE) within the first 72 hours of life in a group of newborns treated with antenatal corticosteroids and in a control group

Incidenza di distress respiratorio neonatale che necessita di supporto ventilatorio (nCPAP, SIPAP, ventilazione meccanica, INSURE) nelle prime 72 ore di vita

E.2.2

Secondary objectives of the trial

1) Type and duration of ventilatory support;
2) Number and type of invasive procedures;
3) Incidence of infections and days of antibiotic therapy;
4)Incidence and type of cerebral lesions detectable by ultrasounds within the 5th week of life (term of gestation);
5)Incidence of breastfeeding with or without additional formula
6)Total number of hospitalization days

1)tipologia e durata del supporto ventilatorio impiegato
2)numero di procedure invasive e tipologia
3)frequenza di infezioni e giorni totali di terapia antibiotica eseguita
4) frequenza e tipologia di lesioni cerebrali ecograficamente rilevabili entro la 5^ settimana di vita (corrispondente al termine di gestazione)
5)frequenza di allattamento materno esclusivo e complementare
6) giorni di degenza ospedaliera del neonato

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Pregnat women with a medical condition which requires an elective preterm cesarean section (34-36 weeks of gestation)

Donne gravide affette da patologia materno/ostetrica tale per cui è programmato un taglio cesareo elettivo dalla 34^ settimana 0/7 giorni alla 36 settimana 6/7 giorni.

E.4

Principal exclusion criteria

1) Major congenital malformation
2) Women with a medical condition which requires a corticosteroids therapy befor enrollment
3) Women already treated with corticosteroids prophylaxis within two weeks from enrollment
4) Women with a cesarean section planned within 12 hours from enrollment
5) P-PROM
6)Maternal condition for which a corticosteroids therapy is controindicated

1)Malformazioni congenite maggiori.
2)Madri con patologia che richiede trattamento con steroidi, già in corso al momento dell’arruolamento.
3)Madri già trattate con ciclo di corticosteroidi prenatali nelle due settimane precedenti la randomizzazione.
4)Donne che siano candidate ad espletare il parto entro 12 ore dalla randomizzazione per condizioni materne e/o fetali
5)P-PROM
6) Donne con patologie che le pongano a rischio di vita in caso di terapia con corticosteroidi

E.5 End points

E.5.1

Primary end point(s)

Reduction of respiratory distresss in premature newborn treated with antenatal corticosteroids

Riduzione del distress respiratorio nel neonato prematuro profilassato con corticosteroidi

E.5.1.1

Timepoint(s) of evaluation of this end point

2 years

2 anni

E.5.2

Secondary end point(s)

1) Type and duration of ventilatory support;
2) Number and type of invasive procedures;
3) Incidence of infections and days of antibiotics therapy;
4)Incidence and type of cerebral lesions detectable by ultrasounds within the 5th week of life (term of gestation);
5)Incidence of breastfeeding with or without additional formula
6)Total number of hospitalization days

E.5.2.1

Timepoint(s) of evaluation of this end point

2 years

2 anni

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

nessun farmaco

no therapy

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

520

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

Yes

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

520

F.4.2

For a multinational trial

F.4.2.1

In the EEA

520

F.4.2.2

In the whole clinical trial

520

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

No particular treatment and/or assistance is planned after the end of the participation to the study

Non è previsto alcun trattamento e/o alcuna assistenza particolare al termine della partecipazione allo studio

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2011-07-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-07-12

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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