| CTRI Number |
CTRI/2024/10/076044 [Registered on: 29/10/2024] Trial Registered Prospectively |
| Last Modified On: |
26/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Beneficial effect of oral application of colostrum or mothers own milk in preterm babies. |
|
Scientific Title of Study
|
To evaluate the beneficial effect of oral application of colostrum or mothers own milk in preterm baby A randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahaveer Singh Lakra |
| Designation |
Assistant professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research,Sawangi Meghe. |
| Address |
Assistant professor, Department of paediatrics, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha.
Wardha MAHARASHTRA 442001 India |
| Phone |
09992693363 |
| Fax |
|
| Email |
lakra.mahaveer@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Amar Taksande |
| Designation |
Professor and HOD |
| Affiliation |
Datta Meghe Institute of Higher Education and Research,Sawangi Meghe. |
| Address |
Jawaharlal Nehru Medical College
Sawangi Meghe
Wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
09822369233 |
| Fax |
|
| Email |
amar.taksande@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Amar Taksande |
| Designation |
Professor and HOD |
| Affiliation |
Datta Meghe Institute of Higher Education and Research,Sawangi Meghe. |
| Address |
Jawaharlal Nehru Medical College
Sawangi Meghe
Wardha
MAHARASHTRA 442001 India |
| Phone |
09822369233 |
| Fax |
|
| Email |
amar.taksande@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research,Sawangi Meghe, Wardha, Maharashtra. 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research, |
| Address |
Sawangi Meghe, Wardha,Maharashtra. India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Mahaveer Lakra |
Acharya Vinoba bhave Rural Hospital |
Room no. 4, Near neonatology OPD area Wardha MAHARASHTRA |
9992693363
lakra.mahaveer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (DU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E649||Sequelae of unspecified nutritional deficiency, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mothers own milk/ colostrum |
Route- Oropharyngeal
Dose- 0.2 ml ofMothers own milk/ colostrum
Duration: Till 32 weeks
Frequency: Every 2 hours for 48 hours, then every 3 hours |
| Comparator Agent |
Normal saline |
Route- Oropharyngeal Dose- 0.2 ml of normal saline Duration: Till 32 weeks Frequency: Every 2 hours for 48 hours, then every 3 hours |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
45.00 Day(s) |
| Gender |
Both |
| Details |
Sick babies with less than 32 weeks of gestation requiring CPAP or ventilation who is not receiving feed directly.
2) Mother plans to pump and provide milk for babies admitted in NICU.
3) NICU admissions less than 24 hrs. of life and inborn babies
4) Ability to begins protocol within 96 hours of life.
|
|
| ExclusionCriteria |
| Details |
Babies having
1. birth asphyxia (cord ph/arterial ph less than7)
2. Presence of significant congenital anomalies
4. Parents not giving consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The serum IgA level values in two groups
The incidence of Ventilatory associated pneumonia |
Oral application of milk - 24 hours
Serum IgA blood values at 7 days of life
Septic Screening at 7-10 days
Discharge or death at the time of discharge 4-6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total days of hospital stay
The incidence of septicaemia and necrotising enterocolitis
Outcome in form of death or discharge |
Subject enrolment at 24 hours of life
Application of milk at 48 hours of life
Estimation of serum IgA level at 7 and 14 days of life
Recording of occurrence of septicaemia and necrotising enterocolitis at any of time
Collection of Mortality data throughout and at the time of discharge |
|
|
Target Sample Size
|
Total Sample Size="128" Sample Size from India="128"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/11/2024 |
| 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="0" Months="11" Days="30" |
|
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: Premature babies are at higher risk for getting infection and necrotizing enterocolitis leading to significant morbidity and mortality. Mothers own milk contain protective enzymes and immunoglobulins which provide antimicrobial, anti-inflammatory and can lower down the rates of infection and necrotizing enterocolitis. Oropharyngeal administration of own mother’s milk may raise serum IgA level which improve the overall outcome of preterm babies. Aim and Objectives: To estimate the salivary IgA level in babies and to corelate the incidence of sepsis and necrotizing enterocolitis with oral application of colostrum and mothers’ own milk (MOM). Design of study: Randomized control trial. Setting: NICU, JNMC Sawangi Meghe. Duration: 1 year Methodology: All inborn babies less than 32 weeks of gestation requiring CPAP and Ventilation and not receiving feed will be included in study. Babies will be allocated in two groups by randomized selection. Interventional group will be applied colostrum to oral mucosa and will receive 0.2 ml of own mother’s own milk via oropharyngeal administration. Control group babies receive a placebo (0.2 ml sterile water) following the same protocol. The serum IgA level will be estimated after 7 days in all babies. The incidence of septicemia, NEC and total stay will be noted down during course of hospital stay. Data collection and analysis: Demographic information will be collected and detailed perinatal history will be noted. The septicemia parameters, abdominal girth, feed intolerance and x ray findings will be noted. The serum IgA levels will be calculated and compared in two groups. The data will be analysed by the STATA 10 software. The chi- square and Fischer’s exact two tail test will be used to study the frequency, odd ratio and p value < 0.05 will be considered significant. Key Words: Colostrum, Mothers own milk, Septicemia, Immunoglobulin, Necrotizing enterocolitis, |