DIAMOND Trial Information

Aim

Our aims are to investigate the impact of different feeding strategies currently in use in New Zealand on feed tolerance, body and microbial composition, and on developmental outcome in MLPT babies. We will address these aims through a factorial design clinical trial, enabling us to assess the effects of each intervention separately, whilst also exploring the effects of interactions.

Objective

Our overall objective is to provide robust evidence to inform feeding practices in moderate- to late-preterm (MLPT) infants that will optimise their growth, metabolic outcomes and development.

To determine the role of (i) parenteral nutrition, (ii) supplementary milk feeds and (iii) the role of taste and smell in MLPT infants whilst waiting for full enteral nutrition with mother’s own milk to be established on feed tolerance, growth, body composition and development.

Study Design

Multi-site, randomised, factorial design, clinical trial.

Study Population

• Born between 32⁺⁰ and 35⁺⁶ weeks’ gestation
• Mother intends to breast-feed
• Admitted to the Neonatal Care Unit
• Requires insertion of intravenous line for clinical reasons

Intervention

(i) Parenteral nutrition vs 10% dextrose intravenously;

(ii) Supplemental milk (donor breast milk if available, else infant formula) vs only mother’s own milk as available;

(iii) Infant exposed to smell and taste of milk prior to every tube feed vs no exposure (milk administered only via gastric feeding tube).

All babies will receive nutrition according to individual neonatal intensive care unit practices. The first two interventions only apply until the baby is established on full enteral feeds with mothers’ own milk, which remains the primary nutritional goal. Babies randomised to receive smell and taste prior to tube feeds will continue to receive this intervention until the baby is no longer receiving any gastric tube feeds.

Outcome Measures

Primary study outcome: For parenteral nutrition (i) and milk supplement (ii) factors: body composition assessment at 4 months' corrected age when infant adiposity is predictive of childhood fat mass measured by air displacement plethysmography (ADP) or skin fold thickness measurements. For smell/taste (iii) factor, time to full enteral feeds defined as 150 mL.Kg^-1.day^-1.

Data/Power Analysis

A total of 480 babies (n=240 per intervention arm) will provide ≥90% power at an overall type 1 error rate of 5% to detect a minimal clinically significant difference in % fat mass at 4 months’ correct age of 3% (lower 95% confidence interval) for parental nutrition and milk supplement interventions, or to detect a reduction in median time to full enteral feeds from 10 to 7 days (hazard ratio 1.43) with smell/taste intervention. Allowing for 10% loss to follow up, we aim to recruit 528 babies (n = 66 per randomised condition).

Commencement Date

February 2017

Investigators and Primary Contacts

Principal investigator: Tanith Alexander, t.alexander@auckland.ac.nz

Liggins Institute, University of Auckland, Private Bag 92019, Auckland 1142, New Zealand

Overall Responsible Investigator: Professor Frank Bloomfield, f.bloomfield@auckland.ac.nz

Liggins Institute, University of Auckland, Private Bag 92019, Auckland 1142, New Zealand

Australia New Zealand Clinical Trials Registry

(ANZCTR) Trial Registry Number: ACTRN12616001199404