| CTRI Number |
CTRI/2017/09/009813 [Registered on: 18/09/2017] Trial Registered Retrospectively |
| Last Modified On: |
01/10/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study comparing growth of preterm babies fed expressed breast milk admitted in the neonatal intensive care unit |
|
Scientific Title of Study
|
Postnatal growth evaluation in preterm babies on expressed breast milk feeding admitted in NICU |
| Trial Acronym |
PoGEM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vishal Vishnu Tewari |
| Designation |
Associate Professor |
| Affiliation |
Army Hospital (Referral and Research) |
| Address |
Department of Pediatrics,
Army Hospital (Referral and Research),
Dhaula Kuan,
New Delhi
South West
DELHI
110010
India |
| Phone |
8826118889 |
| Fax |
|
| Email |
docvvt_13@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vishal Vishnu Tewari |
| Designation |
Associate Professor |
| Affiliation |
Army Hospital (Referral and Research) |
| Address |
Department of Pediatrics,
Army Hospital (Referral and Research),
Dhaula Kuan,
New Delhi
South West
DELHI
110010
India |
| Phone |
8826118889 |
| Fax |
|
| Email |
docvvt_13@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amit Singhal |
| Designation |
PG Student |
| Affiliation |
Army Hospital (Referral and Research) |
| Address |
Department of Pediatrics,
Army Hospital (Referral and Research),
Dhaula Kuan,
New Delhi
South West
DELHI
110010
India |
| Phone |
8800308257 |
| Fax |
|
| Email |
amit.singhal57@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Army Hospital (Referral and Research), Dhaula Kuan, New Delhi - 110010 |
|
|
Primary Sponsor
|
| Name |
Vishal Vishnu Tewari |
| Address |
Department of Pediatrics,
Army Hospital (Referral and Research), Dhaula Kuan, New Delhi - 110010 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Amit Singhal |
Army Hospital (Referral and Research), New Delhi |
Neonatal Intensive Care Unit (NICU), Level 2, Department of Pediatrics,
South West
DELHI |
9971216669
amit.singhal57@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Army Hospital (Referral and Research) Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Preterm neonates below 33 weeks period of gestation admitted to the neonatal intensive care unit, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
7.00 Day(s) |
| Gender |
Both |
| Details |
Intramural preterm neonates below 33 weeks period of gestation requiring admission to the neonatal intensive care unit |
|
| ExclusionCriteria |
| Details |
1. Preterm neonate below 27 weeks period of gestation
2. Preterm neonate more than equal to 33 weeks period of gestation
3. Symmetrical intrauterine growth restricted neonate
4. Preterm intrauterine growth restricted neonate with antenatal Doppler abnormalities
5. Preterm neonate with a life threatening congenital malformation or intestinal anomaly
6. Preterm neonate with dysmorphism
7. Extramural neonate
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean weight gain (in gm per kg per day), mean increase in Occipito-frontal circumference (in cm per week) and mean increase in length (in cm per week) |
Admission till discharge from the neonatal intensive care unit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a. Time to achieve and sustain full feeding for at least 5 successive days
b. Time to regain birth weight
c. Episodes of Feed intolerance requiring interruption of feeds
d. Necrotizing enterocolitis – all stages
e. Late onset sepsis – probable and blood culture positive
f. Duration of oxygen therapy
g. Retinopathy of prematurity
h. All-cause mortality
|
Admission till discharge from the neonatal intensive care unit |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "93"
Final Enrollment numbers achieved (India)="93" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2015 |
| Date of Study Completion (India) |
14/10/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
1. Quigley M, McGuire W. Formula versus donor breast milk for feeding preterm or low birth weight infants. Cochrane Database of Systematic Reviews 2014, Issue 4. Art. No.: CD002971. DOI: 10.1002/14651858.CD002971.pub3
2. Cristofalo EA, Schanler RJ, Blanco CL et al. Randomized trial of exclusive human milk versus preterm formula diets in extremely premature infants. J Pediatr 2013;163:1592-5.
3. Roze ´ J-C, Darmaun D, Boquien C-Y, et al. The apparent breastfeeding paradox in very preterm infants: relationship between breast feeding, early weight gain and neurodevelopment based on results from two cohorts, EPIPAGE and LIFT. BMJ Open 2012;2:e000834. doi:10.1136/ bmjopen-2012-00083.
4. Schanler RJ. Evaluation of the evidence to support current recommendations to meet the needs of premature infants: the role of human milk. Am J Clin Nutr 2007;85(suppl):625S–8S. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is an observational analytical study with 3 cohorts of preterm neonates below 33 weeks of period of gestation who required neonatal intensive care unit (NICU) admission. The neonates in these three cohorts were provided expressed breast milk feeding in the following manner:- a. expressed breast milk going upto 200 ml/kg/day supplemented with Hind-milk b. expressed breast milk upto 150-160 ml/kg/day supplemented with liquid calcium phosphate and liquid multivitamin-micronutrient c. expressed breast milk upto 150-160 ml/kg/day supplemented with multicomponent human milk fortifier powder The goal of preterm nutrition is optimal postnatal growth and expressed breast milk feeding is unarguably the preferred form of milk. However it may not be able to provide the preterm with adequate protein, calcium, sodium, fats and other nutrients. Increasing total enteral intake, addition of hind-milk, fortification with human milk fortifier or supplementation by adding liquid calcium phosphate and multivitamin-micronutrient liquid are different strategies which are adopted with merits and demerits of each. The addition of multicomponent human milk fortifier powder has been shown to increase the risk of late onset sepsis and necrotizing enterocolitis in preterm neonates, while addition of liquid suspension of calcium phosphate results in milk fat chelation and reduced availability of milk fats and fat soluble vitamins and increased risk of feed intolerance. Enteral feeding upto 200 ml per kg per day is tolerated by preterm neonates and may produce optimal growth. Fortifying with hind-milk increases the availability of fats. This reduces the risk of late onset sepsis, NEC and feed intolerance and allows optimal postnatal growth. This study is aimed as ascertaining the most suitable manner of enteral feeding in preterm neonates by using the primary outcome measure of mean weight gain (in gm per kg per day), mean increase in OFC (in cm per week) and mean increase in length (in cm per week). The secondary outcomes which would be studied are time to achieve and sustain full feeding for at least 5 successive days, time to regain birth weight, episodes of feed intolerance requiring interruption of feeds, necrotizing enterocolitis – all stages, late onset sepsis – probable and blood culture positive, duration of oxygen therapy and all-cause mortality. |