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Comparison of Phenobarbital versus Morphine in the management of neonatal abstinence syndrome, a randomized controlled trial

Protocol summary

Summary
Multicentric prospective, randomized, open label, trial on 60 neonates born to illicit drugs addicted mothers and exhibit NAS requiring medical therapy admitted at Vali-Asr and Akbar-Abadi hospitals of Tehran University of Medical Sciences, Tehran, Iran, from April 2009 through February 2014. Inclusion criteria are: 1. neonates born at ≥ 35 weeks of gestation, 2. exposure to addictive drugs in utero 3. demonstration of signs and symptoms of NAS requiring treatment. Exclusion criteria are: 1. neonates born at < 35 weeks of gestation, 2. neonates who had intra uterine growth retardation (IUGR), 3. neonates with congenital anomalies, 4. neonates with major concomitant medical illness requiring oxygen therapy, intravenous fluids or medications, 5. neonates with neurologic abnormality, 6. breastfed neonates, 7. concomitant maternal Benzodiazepine or alcohol use, 8. neonates whose parents refused to give informed consent. After explaining the whole procedure an informed written consent is obtained from the parents, the neonates then will be randomly allocated in 2 groups using the computer random number generator: 1. oral Morphine Sulfate treated group and 2. Phenobarbital treated group. primary outcome of the study is to measure the duration of pharmacologic treatment needed for the resolution of symptoms of NAS. Secondary purposes are duration of hospital stay and requiring adjunctive therapy.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201406239568N8
Registration date: 2014-07-12, 1393/04/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-07-12, 1393/04/21
Registrant information
Name
Golnaz Rezaeizadeh
Name of organization / entity
Maternal Fetal Neonatal Research Center,Tehran University of Medical Sciences, Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2357
Email address
mfnhrc@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
1. Research Deputy of Tehran University of Medical Sciences 2. Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences
Expected recruitment start date
2009-08-15, 1388/05/24
Expected recruitment end date
2014-02-01, 1392/11/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Phenobarbital versus Morphine in the management of neonatal abstinence syndrome, a randomized controlled trial
Public title
Comparison of Phenobarbital versus Morphine in the management of neonatal abstinence syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: 1. neonates born at ≥ 35 weeks of gestation 2. exposure to addictive drugs in utero (determined by maternal history and positive maternal opiate screen during the last trimester of pregnancy) 3. demonstration of signs and symptoms of NAS requiring treatment (3 consecutive Finnegan score of 8 or more or 2 consecutive Finnegan score of 12 or more as calculated every 4 hours by the physician) Exclusion Criteria: 1. neonates born at < 35 weeks of gestation 2. neonates who had intra uterine growth retardation (IUGR) 3. neonates with congenital anomalies 4. neonates with major concomitant medical illness requiring oxygen therapy, intravenous fluids or medications 5. neonates with neurologic abnormality 6. breastfed neonates 7. concomitant maternal Benzodiazepine or alcohol use 8. neonates whose parents refused to give informed consent.
Age
To 5 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Deputy and the Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2009-07-15, 1388/04/24
Ethics committee reference number
88-03-30-9106

Health conditions studied

1

Description of health condition studied
Neonatal Abstinence Syndrome
ICD-10 code
P96.1
ICD-10 code description
Drug withdrawal syndrome in infant of dependent mother

Primary outcomes

1

Description
the duration of pharmacologic treatment needed for the resolution of symptoms of NAS
Timepoint
Every 4 hours the Finnegan Score is measured by the physician till the score falls below 8
Method of measurement
Finnegan Score calculated by the physician every 4 hours

Secondary outcomes

1

Description
The total duration of hospital stay
Timepoint
Measured once at the end of hospital admission
Method of measurement
Measured based on the medical records of the neonate

2

Description
The requirement for adjunctive therapy
Timepoint
Measured daily till the end of neonatal admission
Method of measurement
Measured based on the theraputic and medical records of the neonate

Intervention groups

1

Description
Control Group: In the randomly assigned oral morphine treatment group, initially 1 ml of a 10 mg Morphine Sulfate vial was diluted using 24 ml of distilled water, to make final concentration of 0.4 mg/ml of Morphine, then depending on the Finnegan score drug is administered in 6 divided doses / 24 hours as follow: for a Finnegan score of 8-10: 0.24 mg/kg/24hours (0.6 ml/kg/24hours), for a Finnegan score of 11-13: 0.48 mg/kg/24hours (1.2 ml/kg/24hours), for a Finnegan score of 14-16: 0.64 mg/kg/24hours (1.6 ml/kg/24hours), and for a Finnegan score of 17 and above: 0.8 mg/kg/24hours (2 ml/kg/24hours) of Morphine Sulfate is administered. These doses of Morphine Sulfate continues until Finnegan score remains below 8 for 72 hours then the drug is weaned gradually by 10% of maximal dose every day until it is entirely discontinued at the cessation dose of 0.1 mg/kg/24hours of Morphine Sulfate.
Category
Treatment - Drugs

2

Description
Intervention Group: In the randomly assigned Phenobarbital treatment group, initially a loading dose of 20 mg/kg IV or IM is administered then if the symptoms persists another 5mg/kg is given every 8-12 hours until the entire loading dose would reach a maximum of 40 mg/kg. The maintenance dose is adjusted based on the loading dose and is initiated 12-24 hours after the last loading dose as follow: for a loading dose of 20 mg/kg the maintenance dose is 5 mg/kg/24 hours, for a loading dose of 30 mg/kg the maintenance dose is 6 mg/kg/24 hours, and for a loading dose of 40 mg/kg the maintenance dose is 8 mg/kg/24 hours administered IM or IV. These doses of Phenobarbital continued until Finnegan score remained below 8 for 72 hours then the drug is weaned gradually by 10% of maximal dose every day until it is entirely discontinued.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Vali-Asr Teaching Hospital, Tehran University of Medical Sciences
Full name of responsible person
Dr. Hosein Dalili
Street address
City
Tehran

2

Recruitment center
Name of recruitment center
Akbar-Abadi Teaching Hospital, Tehran University of Medical Sciences
Full name of responsible person
Dr. Kalani
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The Research Deputy of Tehran University of Medical Sciences
Full name of responsible person
Dr. Hosein Dalili
Street address
Vali-Asr Teaching Hospital, Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Research Deputy of Tehran University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

2

Sponsor
Name of organization / entity
Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences
Full name of responsible person
Dr. Mamak Shariat
Street address
Vali-Asr Teaching Hospital, Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Maternal, Fetal and Neonatal Research Center, Tehran University of Medical SCIENCES
Full name of responsible person
Dr. Mahdi Sheikh
Position
Researcher
Other areas of specialty/work
Street address
Maternal, Fetal and Neonatal Research Center, Vali-asr Hospital, Imam Khomeini Hospital complexes, Keshavarz blvd
City
Tehran
Postal code
1419733141
Phone
+98 912 848 1663
Fax
Email
mahdisheikh@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences
Full name of responsible person
Dr. Hosein Dalili
Position
Assistant Professor, Research Fellow
Other areas of specialty/work
Street address
Maternal, Fetal and Neonatal Research Center, Vali-asr Hospital, Imam Khomeini Hospital complexes, Keshavarz blvd
City
Tehran
Postal code
1419733141
Phone
+98 911 141 4608
Fax
Email
hoseindalili@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences
Full name of responsible person
Dr. Mahdi Sheikh
Position
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
+98 912 848 1663
Fax
Email
mahdisheikh@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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