| 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
|
|
|
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
|
|
|
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
|