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CTRI Number  CTRI/2023/09/057574 [Registered on: 13/09/2023] Trial Registered Prospectively
Last Modified On: 06/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Establishing mothers own milk feeding in preterm babies 
Scientific Title of Study   Effectiveness of interventional program on establishing mothers own milk feeding in preterm neonates - A prospective interventional study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shalini T 
Designation  DrNB neonatology resident 
Affiliation  Mehta multispeciality hospitals India Private limited 
Address  Shalini T Mehta multispeciality hospitals India Private limited Chetpet Chennai

Chennai
TAMIL NADU
600031
India 
Phone  9677737473  
Fax    
Email  shalinithangaraj19@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Arun Krishnan 
Designation  Consultant 
Affiliation  Mehta multispeciality hospitals India Private limited 
Address  Mehta multispeciality hospitals India Private limited Chetpet Chennai

Chennai
TAMIL NADU
600031
India 
Phone  9976596999  
Fax    
Email  arunbluewhale@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Shalini T 
Designation  DrNB neonatology resident 
Affiliation  Mehta multispeciality hospitals India Private limited 
Address  Shalini T Mehta multispeciality hospitals India Private limited Chetpet Chennai

Chennai
TAMIL NADU
600031
India 
Phone  9677737473  
Fax    
Email  shalinithangaraj19@gmail.com  
 
Source of Monetary or Material Support  
Mehta Multispeciality Hospitals Private India Limited, Chennai, India - 600031 
 
Primary Sponsor  
Name  Not applicable 
Address  NA 
Type of Sponsor  Other [NA] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrArun KrishnanB  Mehta multispeciality hospitals india private limited, Chennai  Neonatal Intensive Care Unit, Department of Neonatology,Mehta multispeciality hospitals India private limited, Chetpet, Chennai - 600031, Tamil Nadu
Chennai
TAMIL NADU 
9976596999

arunbluewhale@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Mehta Multispeciality Hospitals India Pvt Ltd  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P84-P84||Other problems with newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Counselling   Counselling postnatally through the stay of NICU regarding kangaroo mother care, diet modification, frequent expression of breast milk and benefits of breastmilk. Each counselling session will be given for 20 minutes per day through the stay of NICU of her newborn. 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  30.00 Day(s)
Gender  Both 
Details  Hemodynamically stable preterm neonates less than 34 weeks of gestation 
 
ExclusionCriteria 
Details  Major congenital anomalies  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mothers own milk feeding rates in 34 weeks babies at corrected gestational age of 40 weeks  Corrected gestational age of 40 weeks for each baby 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of babies receiving expressed breast milk on 1st, 7th & 14th day after a structured interventional program
 
On day 1, day 7 & day 14 postmenstrual age 
 
Target Sample Size   Total Sample Size="344"
Sample Size from India="344" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   17/09/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Background:

Breastfeeding is the optimal nutrition for both term and the preterm neonate. But various factors affect the milk production in mothers. Preterm birth itself acts as a stressor and impacts the breastfeeding in preterm mothers. Breastfeeding has a range of health benefits to the breastfeeding dyad. Apart from being economical, it helps reduce the risk of otitis media, respiratory tract infections, asthma and atopy, gastroenteritis and so on. In addition to these benefits, breastfeeding offers improved neuro-developmental outcomes to the premature baby.With increasing preterm births and their related complications, it becomes paramount importance to take measures that affect their morbidity and mortality. Globally, an estimated 13.4 million babies were born preterm in 2020 with preterm complications causing death in approximately 9,00,000 deaths in 2019. This group of infants are born with varying needs including nutrient needs based on their prematurity. Prematurity affects the accretion that happens in the late trimester, making them prone to lack of vital support for their growth and development. Hence, the emphasis on the breastfeeding and usage of mother’s own milk to meet all the needs of the premature baby in a holistic way. But the problem arises due to delayed stage II of lactogenesis, which occurs increasingly in these preterm mothers due to the premature nature of delivery. Hence it becomes important to intervene in this situation, as this delayed lactogenesis may benefit from professional education, interventions and support. Often eligible babies for enteral feedings are kept nil per oral because of non-availability of expressed breast milk and even when established, it becomes a difficult task to successfully discharge a preterm neonate on exclusive mother’s own milk feeding. Hence this study is being undertaken to form a structured intervention protocol to help increase the rates of mother’s own milk feeding in preterm neonates in our institution.


AIM

To evaluate interventions in NICU to increase the exclusive mother’s own milk feeding rates in preterm babies by 20%

OBJECTIVES

Primary:

            To study the effectiveness of interventional program on the proportion of babies receiving exclusive feeds by Mother’s own milk at a corrected gestational age of 40 weeks.

Secondary:

1.     To measure the proportion of babies receiving expressed breast milk on 1st, 7th and 14th day after a structured interventional program

2.     To measure the rate of growth, by weight gain in both the groups.

3.     To measure the rate of necrotizing enterocolitis and sepsis in babies on exclusive mother’s own milk feeding.

4.     To measure the time to reach full enteral feeding



 
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