Benefits of human breast milk bank

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2016/04/006855
• Date of registration: 22-04-2016
• Prospective Registration: Yes
• Primary sponsor: Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER
• Public title: Benefits of human breast milk bank
• Scientific title: Impact of human breast milk bank on the mortality and morbidity pattern in a NICU of a tertiary care hospital
• Date of first enrolment: 02-05-2016
• Target sample size: 230
• Recruitment status: Not Yet Recruiting
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=14209
• Study type: Interventional
• Study design: Randomized, Parallel Group Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Dr Adhisivam
• Affiliation: JIPMER

• Name: Dr Adhisivam
• Affiliation: JIPMER

Key inclusion & exclusion criteria

Inclusion criteria: PDHM will be prescribed on priority for intramural and extramural neonates admitted in JIPMER:

• preterm and sick babies

• babies of mothers with postpartum illnesses

• babies whose mothers have lactation failure, till their mothersâ?? milk output improves.

• only neonates of adult mothers will be included

Others:

• Abandoned neonates

• temporary interruption of breastfeeding

• babies whose mother died in the immediate postpartum period


Exclusion criteria: Exclusion criteria

• Neonates who are not inpatients

• Neonates admitted in other hospitals



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- preterm neonates

Intervention(s)

Intervention1: fortified pasteurized donor human milk (PDHM): After counselling, checking suitability for donation and written informed consent, the donor will be sent to the breast milk collection area where breast milk will be collected under supervision of trained staff nurse with hygienic precautions by breastmilk pump. Raw breast milk will be refrigerated immediately. Breast milk from multiple donors will be pooled to ease processing and storage. Donor milk will be pasteurized at the recommended temperature of 62.5ºC for a period of 30 minutes (Pretoria Holder pasteurization method). Microbiological screening of donor milk will be done as soon as possible after pasteurization. The PDHM will be kept in dedicated freezer. Frozen PDHM would be thawed before administering to the neonate. After obtaining informed consent from the parents, neonates satisfying the inclusion criteria will be randomized prior to starting enteral feeds into two groups using computer generated random numbers kept in opaque sealed envelopes. Infants will be assessed for eligibility and randomization within 24 hrs of life. Aseptic precautions will be taken during fortification with PDHM and for fortification, a commercial human milk fortifier[Lactodex HMF, Raptakos Brett, Composition of HMF (per 2g sachet to be mixed in 50 mL EBM) protein â?? 0.2 g, fat â?? 0.1 g, carbohydrate â?? 1.2 g, vitamin A â??730 i.u, vitamin D â?? 250 i.u, calcium â?? 50 mg, phosphate â?? 25 mg, sodium â?? 1.75 mg and energey â?? 6.5 kcal] will be used. Feeds will be started and advanced according to standard NICU protocol. Nutritional supplements (Vitamin D, Calcium, Iron and Vitamin E) will be added in standard doses once full enteral feeding is achieved (100ml/kg/day). Neonates will be fed with orogastric/ nasogas

Primary Outcome(s)

incidence of Necrotizing enterocolitis (NEC)Timepoint: 0-28 days

Secondary Outcome(s)

severity of NEC, incidence of sepsis, mortality, duration of hospital stay, number of days to full enteral feeds and weight gainTimepoint: 0- 28 days

Secondary ID(s)

NIL

Source(s) of Monetary Support

Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry

Ethics review

Status: Approved
Approval date: 19/11/2015
Contact:

Institute Ethics commitee(human studies), JIPMER