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Comparison of the efficiency of methadone and morphine in reducing the Neonatal Abstinence Syndrome born to addicted mothers

Protocol summary

Study aim
The aim of this study was to identify and compare the effectiveness of methadone and morphine in reducing the Neonatal Abstinence Syndrome in infants born to addicted mothers.
Design
A clinical trial with two groups of 50 people treated with morphine or methadone, double-blind in parallel, randomly and indefinitely treated with two drugs.
Settings and conduct
Random and clinical trial of two-blind trial performed in Afzalipour Hospital in Kerman. Study on 100 infants in two groups and a patient with NAS in which patients in both groups were randomly treated with morphine (n = 50) and methadone (n = 50).
Participants/Inclusion and exclusion criteria
The target population of this study is all infants who were born in 2021 in Afzalipour Hospital in Kerman and were admitted to the NICU ward due to Neonatal Abstinence Syndrome ( ANS) and are receiving medical treatment and their mother was an opioid user. Inclusion criteria: Infants of mothers who have taken morphine derivatives due to abuse or relief of chronic pain and have been visited at least once or twice for pregnancy care in the third trimester are able to survive. Exclusion criteria: 1. Mothers who consume alcohol 2. Congenital and genetic abnormalities. 3. Taking benzodiazepines during pregnancy 4. Infants who are unable to survive or whose survival is in doubt.
Intervention groups
In the two groups of infants with NAS, a comparison of the duration of hospitalization, the duration of treatment and the side effects of morphine and methadone is performed.
Main outcome variables
Duration of hospitalization Duration of treatment Side effects of the drugs used

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100202003250N7
Registration date: 2024-10-17, 1403/07/26
Registration timing: retrospective

Last update: 2024-10-17, 1403/07/26
Update count: 0
Registration date
2024-10-17, 1403/07/26
Registrant information
Name
Bahareh Bahman Bijari
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1322 2250
Email address
bbbijari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2022-04-20, 1401/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficiency of methadone and morphine in reducing the Neonatal Abstinence Syndrome born to addicted mothers
Public title
Comparison of the efficiency of methadone and morphine in reducing the Neonatal Abstinence Syndrome born to addicted mothers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infants of mothers who have taken morphine derivatives due to abuse or relief of chronic pain and have been visited at least once or twice for pregnancy care in the third trimester and are able to survive.
Exclusion criteria:
Mothers who consume alcohol Congenital and genetic abnormalities. Taking benzodiazepines during pregnancy Infants who are unable to survive or whose survival is in doubt.
Age
From 1 day old to 28 days old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of the unit is done in a block method with a block size of 4. For each of the 6 possible modes for the block of four, the numbers are assigned as follows, ABBA(3), ABAB(2), AABB(1), BAAB(6), BABA(5), BBAA(4) with the help of the table Random numbers, numbers between 1 and 6 are selected and determined according to each number of the treatment allocation list. To implement the generated random sequence, the method of hiding the box or coded cans is used. In this method, the cans are numbered based on a random sequence, and inside the boxes, the intended intervention (medicine) or a sheet with random allocation written on it, provided that the boxes are completely sealed, is provided to the operator. Based on the order of arrival of the patients, the researcher assigns them to the intervention and standard treatment group. Tools: Creating a random sequence of 4 random blocks, concealment will be done to implement the random sequence on the participants of the study. How to build: random selection of blocks and reading letters from right to left, hiding will be done by the method of cans that are numbered based on a random sequence. The cans have the same weight and shape and will be prepared by an independent researcher.
Blinding (investigator's opinion)
Double blinded
Blinding description
Morphine and methadone are placed in two identical bottles of the same color and appearance, the inside of which is unknown, which the clinical caregiver and the nurse are unaware of the type of drug prescribed.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Afzalipour Hospital, Next to Shahid Bahonar University, Imam Khomeini Highway
City
کرمان
Province
Kerman
Postal code
7616913355
Approval date
2021-09-08, 1400/06/17
Ethics committee reference number
IR.KMU.AH.REC.1400.182

Health conditions studied

1

Description of health condition studied
Neonatal Abstinence Syndrome
ICD-10 code
P96.1
ICD-10 code description
Neonatal withdrawal symptoms from maternal use of drugs of addiction

Primary outcomes

1

Description
Duration of hospitalization
Timepoint
Duration of hospitalization
Method of measurement
Therapist's observations

2

Description
Duration of treatment
Timepoint
Duration of hospitalization
Method of measurement
Therapist's observations

3

Description
Side effects of drugs
Timepoint
Duration of hospitalization
Method of measurement
Therapist's observations

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1 (morphine): In this group, there are 50 patients who are receiving morphine drug treatment. The decision to start drug treatment will be based on the Fingan scoring system. When there is an adequate Fingan standard score (three consecutive Fingan scores greater than 8 or three consecutive Fingan scores greater than 12) for drug treatment, the infant receives the drug under randomized type of drug. In this group, 1 cc of morphine is diluted with 24 cc of distilled water and given to infants. For these infants, the starting dose of treatment will be 0.3-0.2 mg / kg body weight per day divided every 6 hours. The dose of the drug will be evaluated each time based on the score of the Fingan table. If the score of Fingan is higher than 12, the next dose will be added 10% to the dose of the drug, and if the score of Fingan reaches less than 8, the dose of the drug will be reduced again by 10% for the next time. After 48 hours of controlled symptoms (Fingan score between 8 and 12) daily reduced by 10% of the previous maximum dose to below 0.1 mg per kg per day and then morphine will be discontinued. After 48 hours of monitoring, the infant will be discharged.
Category
Treatment - Drugs

2

Description
Intervention group 2 (methadone): There are 50 patients in this group who are receiving methadone drug treatment. The decision to start drug treatment will be based on the Fingan scoring system. When there is an adequate Fingan standard score (three consecutive Fingan scores greater than 8 or three consecutive Fingan scores greater than 12) for drug treatment, the infant receives the drug under study based on a random method of drug type. In this treatment group, the intervention method will be that an oral dose should be given every 6 hours. The starting dose should be 100 µg / kg, each time a higher dose is increased until the symptoms are controlled, increasing to 50 /g / kg every 12 hours. The methadone dose should be reduced by 10 to 20% once a day. After 48 hours of monitoring, the infant will be discharged.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Leila Razi
Street address
Afzalipour Hospital, next to Shahid Bahonar University, Imam Khomeini Highway
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
baran3130672451@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin Iranpour
Street address
Vice-Chancellery for Research, Ebn-e-Sina St.,Jahad Blvd. Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
iranpourabedin89@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Bahareh Bahman Bijari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
Afzalipour hospital
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 1322 2250
Fax
+98 34 1322 2763
Email
bbbijari@kmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Bahareh Bahman Bijari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
Afzalipour hospital
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 1322 2250
Fax
+98 34 1322 2763
Email
bbbijari@kmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Bahareh Bahman Bijari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
Afzalipour hospital
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 1322 2250
Fax
+98 34 1322 2763
Email
bbbijari@kmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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