IRCT | Effect of prophylactic caffeine on the sleep/wake cycles (SWC) in preterm neonates with RDS treated with nasal CPAP with a gestational age of 28-35 weeks.

Protocol summary

Study aim: We will investigate the effect of caffeine on the sleep-wake cycle (SWC) in neonates with gestational age of 28-35 weeks with respiratory distress syndrome (RDS} requiring nasal CPAP (nCPAP) by using amplitude-integrated EEG (aEEG).
Design: This study is a single blinded interventional randomized controlled clinical trial phase 3 with two parallel groups (17 neonates in each group). They will randomly allocate by permutation random block method with blocks of 4 in two groups of caffeine treatment (F) and control group (C).
Settings and conduct: The study will be conducted in the neonatal intensive care unit at shahid-beheshti hospital in Isfahan, Iran. The eligible infants randomly assigned to caffeine and control groups since birth. After 48 hours of birth, the sleep-wake cycles of neonates in both groups will be monitored by aEEG for 24 hours.
Participants/Inclusion and exclusion criteria: Inclusion criteria include neonates with gestational age of 28-35 weeks and spontaneous breathing who are under nCPAP support due to RDS. Exclusion criteria are infants who have perinatal asphyxia; congenital brain anomalies; evidence of Patent Ductus Arteriosus (PDA) in echocardiography; evidence of intraventricular Hemorrhage (IVH) grade III oIV in cranial ultrasonography; existence of air leak; tachycardia ( HR more than 180 beat/min) during study and neonates who do not need nCPAP after 48 hour of birth.
Intervention groups: The eligible infants will be randomly assigned into two groups of caffeine (F) or control (C). Infants in the F group received 20 mg/kg caffeine as the initial dose since birth, and then it will continue with 10 mg/kg daily as the maintenance dose until discontinuation of nCPAP and oxygen administration. Infants in the C group will not receive any placebo or similar drugs.
Main outcome variables: The effect of caffeine on the number and duration of sleep-wake cycle of neonate.

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20170627034782N3

Registration date: 2022-07-06, 1401/04/15

Registration timing: prospective

Last update: 2022-07-06, 1401/04/15

Update count: 0
Registration date: 2022-07-06, 1401/04/15

Registrant information: Name

Ramin Iranpour

Name of organization / entity

Isfahan University of Medical Sciences

Country

Iran (Islamic Republic of)

Phone

+98 31 3386 8247

Email address

iranpour@med.mui.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2022-09-23, 1401/07/01
Expected recruitment end date: 2023-03-20, 1401/12/29
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Effect of prophylactic caffeine on the sleep/wake cycles (SWC) in preterm neonates with RDS treated with nasal CPAP with a gestational age of 28-35 weeks.

Public title: Effect of prophylactic caffeine on the sleep/wake cycles (SWC) in preterm neonates.
Purpose: Diagnostic
Inclusion/Exclusion criteria: Inclusion criteria:

Preterm neonate with a gestational age of 28-35 weeks, Spontaneous breathing with clinical sign and symptom of RDS requiring nasal CPAP.

Exclusion criteria:

Perinatal Asphyxia ( apgar score fifth minute=0-3, umbilical cord PH<7, umbilical cord bicarbonate <12 meq/l), Evidence of PDA which is confirmed by echocardiography, Evidence of IVH ( grade 3-4) which is confirmed by cranial sonography, Existence of air leakage, Neonate with congenital brain anomaly, Neonate with tachycardia (heart rate >180), Neonate not requiring nasal CPAP till 48 hours after birth.
Age: From 1 day old to 1 day old
Gender: Both

Phase

3

Groups that have been masked

Participant

Sample size

Target sample size: 34

Randomization (investigator's opinion)

Randomized

Randomization description

The study sample was randomly allocated by permutation random block method with blocks of 4 in two groups of caffeine treatment (F) and control group (C).

Blinding (investigator's opinion)

Single blinded

Blinding description

Only neonates participating in the study are not aware of the drug prescription.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Isfahan University of Medical Sciences, Isfahan, Iran

Street address

Research deputy, Isfahan University of Medical Sciences, Hezarjerib Blvd.

City

Isfahan

Province

Isfehan

Postal code

8184757851
Approval date: 2022-07-02, 1401/04/11
Ethics committee reference number: IR.MUI.MED.REC.1401.145

Health conditions studied

1

Description of health condition studied: The effect of caffeine in quantity and quality of sleep/wake cycle in newborns by using of aEEG
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description: The number of sleep-wake cycle during of one 24 hour
Timepoint: From 48 hours after birth till 24 hour later continuously.
Method of measurement: Brain monitoring with amplitude Electroencephalography (aEEG)

Secondary outcomes

1

Description: apnea of prematurity
Timepoint: 24 hour cardio-respiratory monitoring
Method of measurement: pulse oximeter with Spo2 continuous monitoring

2

Description: The mean duration of active phase of sleep
Timepoint: From 48 hours after birth till 24 hour later continuously.
Method of measurement: Brain monitoring with amplitude Electroencephalography (aEEG).

3

Description: The mean duration of quiet phase of sleep.
Timepoint: From 48 hours after birth till 24 hour later continuously.
Method of measurement: Brain monitoring with amplitude Electroencephalography (aEEG).

4

Description: The mean heart rate.
Timepoint: Every 6 hour, since birth till 72 hour after birth
Method of measurement: Cardio-respiratory monitoring by pulse oximeter.

5

Description: The mean arterial oxygen saturation.
Timepoint: Every 6 hour, since birth till 72 hour after birth
Method of measurement: Every 6 hour, since birth till 72 hour after birth

6

Description: chronic lung disease
Timepoint: Daily
Method of measurement: Physical exam and chest xray

Intervention groups

1

Description: Intervention group: In the caffeine group (F), the premature neonates with a gestational age of 28- 35 weeks with RDS and requiring nCPAP will be receive 20 mg/kg caffeine as the initial dose since birth, and then it will continue with 10 mg/kg daily as the maintenance dose until discontinuation of nCPAP and oxygen administration. After 48 hours of birth, the sleep-wake cycles of neonates will be monitored by aEEG for 24 hours.
Category: Diagnosis

2

Description: Control group: In the control group (C), the premature neonates with a gestational age of 28- 35 weeks with RDS and requiring nCPAP will be will not receive any placebo or similar drugs. After 48 hours of birth, the sleep-wake cycles of neonates will be monitored by aEEG for 24 hours.
Category: Diagnosis

Recruitment centers

1

Recruitment center: Name of recruitment center

shahid-Beheshti Hospital, Isfahan

Full name of responsible person

Ramin Iranpour

Street address

No.16, Sout Resalat St., Mardavij Ave.

City

Isfahan

Province

Isfehan

Postal code

8168967893

Phone

+98 913 113 1653

Email

iranpour@med.mui.ac.ir

Web page address

https://mui.ac.ir

1

Sponsor: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

ِDr Mansour Siavash Dastjerdi

Street address

Hezar-jerib street, Isfahan University of Medical Sciences, Deputy of research and technologyBuilding number 4,

City

Isfahan

Province

Isfehan

Postal code

8174673461

Phone

+98 31 3668 7898

Fax

+98 31 3668 8138

Email

research@mui.ac.ir

Web page address

http://research.mui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Esfahan University of Medical Sciences
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Dr Ramin Iranpour

Position

Neonatologist/Associate Professor

Latest degree

Subspecialist

Other areas of specialty/work

Pediatrics

Street address

Mardavij avenue, Resalat Jonobi, Number16

City

Isfahan

Province

Isfehan

Postal code

8168967893

Phone

+98 31 3668 1555

Fax

Email

iranpour@med.mui.ac.ir

Web page address

http://mui.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Dr Ramin Iranpour

Position

Neonatologist/Associate Professor

Latest degree

Subspecialist

Other areas of specialty/work

Pediatrics

Street address

Mardavij avenue, Resalat Jonobi, Number16

City

Isfahan

Province

Isfehan

Postal code

8168967893

Phone

+98 31 3668 1555

Fax

Email

iranpour@med.mui.ac.ir

Web page address

http://mui.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Ramin Iranpour

Position

Associate professor of Pediaitrics in Isfahan Medical Faculty

Latest degree

Subspecialist

Other areas of specialty/work

Pediatrics

Street address

No. 16, Sout Resalat St, Mardavij Ave

City

Isfahan

Province

Isfehan

Postal code

8168967893

Phone

+98 31 3668 1555

Email

ramin.iranpour@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD): No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD: There is no further information.
Study Protocol: No - There is not a plan to make this available
Statistical Analysis Plan: Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form: Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report: Undecided - It is not yet known if there will be a plan to make this available
Analytic Code: Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary: Undecided - It is not yet known if there will be a plan to make this available

Effect of prophylactic caffeine on the sleep/wake cycles (SWC) in preterm neonates with RDS treated with nasal CPAP with a gestational age of 28-35 weeks.