Author:
Mills Luke,Chappell Karyn E,Emsley Robby,Alavi Afshin,Andrzejewska Izabela,Santhakumaran Shalini,Nicholl Richard,Chang John,Uthaya Sabita,Modi Neena
Abstract
AbstractObjectiveUncertainty exists regarding optimal supplemental diet for very preterm infants if mother’s own milk (MM) is insufficient. We evaluated feasibility for a randomised controlled trial (RCT) powered to detect important differences in health outcomes.MethodsIn this open, parallel, feasibility trial, we randomised infants 25+0-31+6 weeks gestation by opt-out consent, to one of three diets: unfortified human milk (UHM) (unfortified MM and/or unfortified pasteurised human donor milk (DM) supplement; fortified human milk (FHM) (fortified MM and/or fortified DM supplement), and unfortified MM and/or preterm formula (PTF) supplement from birth to 35+0 weeks post menstrual age. Feasibility outcomes included opt-outs, adherence rates, and slow growth safety criteria. We also obtained anthropometry, and magnetic resonance imaging body composition data at term and term plus 6 weeks (opt-in consent).Results35 infants were randomised to UHM, 34 to FHM, and 34 to PTF groups, of which 21, 19, and 24 infants completed imaging at term. Study entry opt-out rate was only 38%, while 6% of parents subsequently withdrew from feeding intervention. Two infants met predefined slow weight gain thresholds. There were no significant between-group differences in total adipose tissue volume at term (mean (sd): UHM: 0.870L (0.35L); FHM: 0.889L (0.31L); PTF: 0.809L (0.25L), p=0.66), nor in any other body composition measure or anthropometry at either timepoint.ConclusionsRandomisation to UHM, FHM, and PTF feeding interventions by opt-out consent was acceptable to parents and clinical teams, associated with safe growth profiles and no significant differences in body composition. Our data provide justification to proceed to a larger RCT.
Publisher
Cold Spring Harbor Laboratory