Protocol summary

Study aim
Comparison weight gain of preterm infant and milk volume of mother in study groups
Design
Clinical trial study with intervention, placebo and control groups. Participants will be assigned in 6 blocks.
Settings and conduct
It is randomized clinical trail study with 3 group on 135 lactating women with preterm infant will be performed in NICU Akbarabadi hospital. Interventional group will receive 2 gr dry herbal tea of anisum in addition 1gr black tea and placebo group will receive 3 gr black tea. Mothers will consume 3 times in day of tea bag during 1 week. Mothers put 1 tea bag in glass and add 150 ml water on it and after 10 minute will drink.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Mothers interest to exclusive breastfeeding, mothers interest to pumping breast, have minimum 18 years old, have normal body mass index, present of mother in hospital in special room for mother and neonate, preterm infant with gestational age less than 32 weeks, Infant hospitalization in NICU fed with NG tube. Exclusion criteria: Use of cigarette, alcohol and drugs, use of any galactogogue and complementary drug, affliction of mother to infectious transferable diseases from lactating such as HIV and active pulmonary Tuberculosis, history of infertility, diabetic mother, mother use of anticoagulation, mothers with cancer related to estrogen, mother with psychological disorder, lack of breast growth in prenatal period, performance of breast surgery, existence of some illness of mother such as mastectomy, inverted nipple, abscess, and infection mastitis, existence of congenital anomalies such as harelip and cleft palate, twin neonates.
Intervention groups
The Pimpinella anisum tea group will receive 2 grams of dried anise plant plus 1 gram of black tea and the placebo group will receive tea containing 3 grams of dried black tea.
Main outcome variables
Increased breast milk volume

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180427039436N9
Registration date: 2021-04-14, 1400/01/25
Registration timing: prospective

Last update: 2021-04-14, 1400/01/25
Update count: 0
Registration date
2021-04-14, 1400/01/25
Registrant information
Name
Leila Amiri Farahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1139
Email address
l.amirifarahani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-24, 1400/03/03
Expected recruitment end date
2021-09-25, 1400/07/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Pimpinella anisum herbal tea on milk volume in mothers and weight gain of preterm infant
Public title
The effect of Pimpinella anisum herbal tea on milk volume in mothers and weight gain of preterm infant
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers interest to exclusive breastfeeding Mothers interest to pumping breast with electronic pumping from third day of postpartum Have ability to read and write Have minimum 18 years old Have normal body mass index from 18.5 to 24.9 kg/m2 Present of mother in hospital in special room for mother and neonate on duration of study Preterm infant with gestational age less than 32 weeks Infant hospitalization in NICU fed with NG tube
Exclusion criteria:
Use of cigarette, alcohol and drugs Use of any galactogogue and complementary drug Affiliction of mother to infectious transferable diseases from lactating such as HIV and active pulmonary Tuberculosis History of infertility Diabetic mother Mother use of anticoagulation Mothers with cancer related to estrogen Mother with psychological disorder based on mother's self-report Lack of breast growth in prenatal period Performance of breast surgery Existence of some illness of mother such as mastectomy, inverted nipple, abscess, and infeection mastitis Existence of congenital anomalies such as harelip and cleft palate Twin neonates
Age
From 8 months old to 8 months old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 135
Randomization (investigator's opinion)
Randomized
Randomization description
sample will be intered continuously in study and will be randomized in 6 blocks with 3 groups in parallel arms in interventional, placebo and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
There is no possibility of blinding in the present study due to having a control group and only to increase the accuracy of the study, the researcher will not know the content of herbal teas given to individuals in each group.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran university of medical sciences
Street address
Tehran, Valiaasr ave, Rashid yasami Ave, infront of Khatamol anbiaa hospital
City
Tehran
Province
Tehran
Postal code
1981111198
Approval date
2021-03-14, 1399/12/24
Ethics committee reference number
IR.IUMS.REC.1399.1417

Health conditions studied

1

Description of health condition studied
The effect of Pimpinella anisum herbal tea on milk volume in mothers and weight gain of preterm infant
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Determination of milk volume in mothers
Timepoint
1,2,3,4,5,6 and 7 days of study measurement of milk volume in mothers
Method of measurement
measurement of milk volume in mothers through Sweetheart medela

Secondary outcomes

1

Description
Determination of weight gain of preterm infant
Timepoint
0 days of study (before study) third days of study and seventh days of study measurement of weight gain of preterm infant
Method of measurement
Measurement of weight of preterm infant through seca scale production of Germane county

Intervention groups

1

Description
Intervention group: The intervention group will receive Pimpinella anisum tea containing 2 grams of dried anise plant plus 1 gram of black tea and the placebo group will receive tea containing 3 grams of dried black tea.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Akbar abadi hospital
Full name of responsible person
Sona Khalili
Street address
Tehran, Valiaasr ave, Rashid yasami Ave, infront of Khatamol anbiaa hospital
City
Tehran
Province
Tehran
Postal code
1981111198
Phone
+98 21 4365 1139
Email
sonakhalili289@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abbas Motevalian
Street address
Shahid hemat highway, Direction2
City
Tehran
Province
Tehran
Postal code
1981111198
Phone
+98 21 6543 3911
Email
L.amirifarahani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Lelila Amirifarahani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Tehran, Valiaasr ave, Rashid yasami Ave, infront of Khatamol anbiaa hospital
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1139
Email
L.amirifarahani@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Amirifarahani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Tehran, Valiaasr ave, Rashid yasami Ave, infront of Khatamol anbiaa hospital
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1139
Email
L.amirifarahani@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila amirifarahani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Tehran, Valiaasr ave, Rashid yasami Ave, infront of Khatamol anbiaa hospital
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1139
Email
L.amirifarahani@gmail.com
Web page address

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
Undecided - It is not yet known if there will be 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
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