The effect of oral consumption of lettuce syrup on breast milk volume and weight gain of preterm infants

Phase 3

Conditions: The effet of oral consumption of Lactuca sativa syrup on breast milk volume and weight gain of preterm infant.
Preterm [premature] newborn [other]
P07.3

Registration Number: IRCT20180427039436N12

Lead Sponsor: Iran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 144

Inclusion Criteria

have minimum 18 years old
Mother's ability to read and write
Have normal maternal body mass index (18/5 - 24/9 kg / m2)
mothers interest to exclusive breastfeeding
mothers interest to pumping breasts witt electronic pumping from third day of postpartum
presence of the mother in the hospital during the study
Preterm infant with gestational age less than 32 weeks
Infant hospitalization in NICU fed with NG tube

Exclusion Criteria

Use of cigarette, alcohole and drugs
Use of any galactagogue and complementary drug
History of infertility
Affiliction of mother to infectious transferable diseases from lactating such as HIV and active pulmonary tuberculosis
Diabetic mother
Mothers with cancer related to estrogen
Mother use of anticoagulants
Mother use of psychiatric drugs
Breast problems such as abscesses, inverted nipples, mastitis or cancer
Breast surgery
Existence of congenital anomalies such as cleft palate and cleft lip
Supplementation by the infant
Twin or multiple infants

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determining breast milk volume. Timepoint: Measurement of breast milk volume on days 1, 2, 3, 4, 5, 6 and 7 of the study. Method of measurement: Measurement of milk volume in mothers through sweetheart medela AND.;Determining weight gain of preterm infant. Timepoint: Measurement of preterm infant weight on day one (before intervention), day three and day seven. Method of measurement: Measurement of weight of preterm infant through a Seca scale production of Germane.

Secondary Outcome Measures

Name	Time	Method
Pharmacological complication. Timepoint: During one week of study. Method of measurement: Mothers will notify the researcher whose telephone number is provided to the mothers if they notice any allergies or complications during the study.The researcher registers the complication in the drug side effects registration form and takes the appropriate action.