N/A
N=5,716
Optimising Newborn Nutrition During Therapeutic Hypothermia.
Infant, Newborn · Asphyxia Neonatorum · Hypothermia, Induced · Parenteral Nutrition · Infant Nutrition
Bottom Line
View on ClinicalTrials.gov: NCT03278847 ↗Enrolled (actual)
5,716
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Necrotising Enterocolitis - for the Enteral Nutrition Comparison — NA; NA; NA; 7 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Received enteral (milk) feeds during therapeutic hypothermia (Dietary_supplement); Enteral (milk) feeds withheld during therapeutic hypothermia (Dietary_supplement); Received parenteral nutrition during therapeutic hypothermia (Dietary_supplement); Did not receive parenteral nutrition during therapeutic hypothermia (Dietary_supplement)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Necrotising Enterocolitis - for the Enteral Nutrition Comparison |
NA; NA; NA; 7 | — |
| PRIMARY Blood Stream Infection - for the Parenteral Nutrition Comparison |
NA; 8; 11; NA | — |
| SECONDARY Survival |
1552; 1465; 1154; 1116 | — |
| SECONDARY Length of Stay |
12.7; 14.8; 15.0; 14.1 | — |
| SECONDARY Breastfeeding |
883; 752; 575; 582 | — |
| SECONDARY Hypoglycaemia |
293; 269; 212; 235 | — |
| SECONDARY Duration of Central Venous Line |
4.3; 5.5; 6; 5.1 | — |
| SECONDARY Growth |
-0.54; -0.6; -0.65; -0.66 | — |
Summary
The overarching aim of this project is to determine the optimum enteral and parenteral nutrition strategy for newborns with Hypoxic Ischaemic Encephalopathy (HIE) during and after therapeutic hypothermia. To do this the investigators will perform two primary comparisons:
1. ENTERAL: to determine whether any enteral (milk) feeding, when compared to withholding enteral feeding (no milk), during therapeutic hypothermia, is associated with a difference in the incidence of necrotising enterocolitis.
2. PARENTERAL: to determine whether provision of intravenous dextrose, when compared to provision of parenteral nutrition, during therapeutic hypothermia, is associated with a difference in the incidence of blood stream infection.
The investigators will use de-identified data held in an established research database called the National Neonatal Research Database (NNRD) and we will use the potential outcomes framework with application of propensity scoring to define matched subgroups for comparison.
Eligibility Criteria
Inclusion Criteria
- Received neonatal care at a unit that is part of the UK Neonatal Collaborative; this includes all NHS neonatal units in England, Scotland and Wales
- Recorded gestational age at birth ≥36 weeks
- Recorded as receiving therapeutic hypothermia for 72 hours or died during therapeutic hypothermia
Exclusion Criteria
- Infants with missing data for principal background and outcome variables.
Data sourced from ClinicalTrials.gov (NCT03278847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.