PREterM FOrmula Or Donor Breast Milk for Premature Babies (PREMFOOD)

Imperial College London

Status: Completed

Conditions: Metabolomic Profile; Insulin Resistance; Adiposity; microRNA Profile

Treatments: Other: Preterm Formula used when there is a shortfall in mother's own milk; Other: Fortified Human donor Milk used to make up any shortfall in mother's own milk; Other: Unfortified Human donor Milk used to make up any shortfall in mother's own milk

Study type: Interventional

Funder types: Other

Identifiers

NCT01686477

CRO2006

Details and patient eligibility

About

In order to address this crucial question, central to preterm newborn care, a multicentre United Kingdom (UK) -wide study randomising 4000 preterm babies would be necessary to achieve sufficient power to evaluate the impact on the short-term outcomes necrotising enterocolitis and bloodstream infection, and establish cohorts large enough to address long-term metabolic (such as obesity, type 2 diabetes), cardiovascular (such as blood pressure) and developmental outcomes. This pilot trial will evaluate the practicability and feasibility of such a large multicentre UK randomised controlled trial. In addition to evaluating feasibility and to ensure maximal use of resources allocated, this study will also assess outcomes that are indicative of long term metabolic health.

Full description

Mother's Own Milk (MOM) is recommended for preterm babies. However, on average, mothers giving birth preterm are able to provide less than half their baby's milk requirements. Standard clinical practice is to make up any shortfall in MOM with either pasteurised Human Donor Milk (HDM) or Preterm Formula (PTF). Which option is more beneficial to clinical outcomes is unknown.

Pasteurisation reduces or destroys many biologically active components and HDM, unlike PTF, is very variable in composition. Clinicians who use HDM do so primarily in the hope that despite pasteurisation it will reduce bloodstream infection and necrotising enterocolitis, a serious, devastating inflammatory disease characterised by bowel death and multisystem failure. These are two of the most feared conditions in newborn medicine as described above. Landmark nutritional trials in the early 1980's suggest positive effects of human milk on insulin sensitivity, and other metabolic outcomes. Clinicians who prefer PTF believe it benefits growth, including brain growth, and improves neurodevelopmental outcome.

Neonates born below 32 weeks gestational age will be randomised to receive fortified HDM, unfortified HDM, or PTF to make up any shortfall in MOM until 35 weeks postmenstrual age with a sample size of 22 in each group. The trial is designed to reflect current preterm feeding practice. The trial will take place in neonatal units in London and parent consent obtained within 48hr of birth. Permission will be sought for long term follow up, initially from parents (later from children themselves). Outcomes will be body composition using magnetic resonance imaging and other imaging techniques. This pilot study will specifically assess feasibility by testing 1) provision of HDM by Human Milk Banks in London 2) acceptability to parents and clinicians using feedback on trial design 3) recruitment to target and 4) retrieval of clinical data for all recruited babies form the National Neonatal Database.

Enrollment: 103 patients

Sex: All

Ages: 25 to 31 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Preterm infants born between 25+0 to 31+6 weeks gestational age
• Written informed consent from parents

Exclusion criteria

• Major congenital or life threatening abnormalities or congenital abnormalities that preclude early milk feeding
• Inability to randomise infant within 48 hours

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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103 participants in 3 patient groups

Unfortified Human Donor Milk

Active Comparator group

Description:

Used to make up any shortfall in mother's own milk

Treatment:

Other: Unfortified Human donor Milk used to make up any shortfall in mother's own milk

Fortified Human Donor Milk

Active Comparator group

Description:

Used to make up any shortfall in mother's own milk

Treatment:

Other: Fortified Human donor Milk used to make up any shortfall in mother's own milk

Preterm Formula

Active Comparator group

Description:

Used to make up any shortfall in mother's own milk

Treatment:

Other: Preterm Formula used when there is a shortfall in mother's own milk