A clinical trial to compare the effect of two traditional breast stimulation techniques on quantity of expressed breast milk among mothers of newborn admitted in NICU

Not yet recruiting

• Conditions: post partum mothers

• Registration Number: CTRI/2020/12/030109
• Lead Sponsor: Asha K Abraham

Brief Summary

This study is  a randomised cross over  trial to compare the quantity of breast milk  expressed following   breast simulation using  breast  massage versus  warm  compress  among  88 lactating mothers who are exclusively  expressing  breast milk for newborn admitted to NICU.  Thia study will be conducted in a quaternary hospital in India  and  willl measure the  volume of expressed  breast milk   following two traditional  breast stimulation  techniques as primary outcome .  The  quality of expressed breast milk  expressed  after rwo breast stimulation  techniques will be  compared for the esterified fat content as a secondary outcome  in addition to  maternal outcomes viz  breast milk expression  experience  and nipple pain .

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-12-28
• Study Start: 2021-01-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 88

Inclusion Criteria

• •Mother of neonate who is admitted in NICU.
• •Mother of neonate who is in 3 to 14 days of post partum period.
• •Mother of neonate who is exclusively fed on expressed breast milk.
• •Mother who is not having any complication during puerperium.
• •Mother who is on routine ante natal and post natal drugs such as supplements of iron ,folic acid, calcium, analgesics , and routine antibiotics and obstetric drugs as per hospital policy.

Exclusion Criteria

• •Mothers diagnosed with breast abscess, mastitis , with breast engorgement, cracked nipple and with the history of any previous breast surgeries.
• •Mother taking any special medications such as chemotherapy drugs, ART drugs, immuno suppressants, thyroxine supplements like eltroxin, Insulin and lactation suppression agents.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Volume of expressed breast milk in ml	8 hours

Secondary Outcome Measures

Name	Time	Method
Quality of breast milk in terms of esterified fat contents assessed by crematocrit method	8 hrs
breast milk expression experience assessed by breast milk expression experience measure	8 hrs
Nipple pain	8 hrs

Trial Locations

Locations (1)

Army Hospital Referral and Research Centre; 🇮🇳 West, DELHI, India

Army Hospital Referral and Research Centre

🇮🇳West, DELHI, India

Asha K Abraham

Principal investigator

917899339164

ashakabraham15@gmail.com