N/A
N=97,507
Outcomes Following Early Parenteral Nutrition Use in Preterm Neonates
Neonatal Death · Prematurity
Bottom Line
View on ClinicalTrials.gov: NCT03767634 ↗Enrolled (actual)
97,507
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Use of Parenteral Nutrition (Project A) — 62145 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Parenteral nutrition (Other)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Use of Parenteral Nutrition (Project A) |
62145 | — |
| PRIMARY Survival to Discharge Home (Project B) |
7987; 8057 | — |
| SECONDARY Late Onset Sepsis (Project B) |
59; 179 | — |
| SECONDARY Necrotising Enterocolitis (Project B) |
285; 660 | — |
| SECONDARY Brain Injury on Imaging (Project B) |
48; 73 | — |
| SECONDARY Retinopathy of Prematurity (Project B) |
272; 297 | — |
| SECONDARY Bronchopulmonary Dysplasia (Project B) |
302; 619 | — |
| SECONDARY Need for Surgical Procedures (Project B) |
69; 147 | — |
| SECONDARY Seizures (Project B) |
81; 114 | — |
| SECONDARY Weight (Project B) |
0.073; -0.024 | — |
| SECONDARY Head Circumference (Project B) |
— | — |
| SECONDARY Blindness (Project B) |
— | — |
| SECONDARY Deafness (Project B) |
— | — |
| SECONDARY Ability to Walk (Project B) |
— | — |
Summary
BACKGROUND
An essential part of neonatal care is providing nutrition to ensure that babies grow and develop. Providing this can be difficult in premature babies because their intestines are underdeveloped. They often have difficulty digesting milk so feeds are introduced gradually. To help babies grow and develop during this period, additional nutrition may be provided as a fluid into a vein; this is called "parenteral nutrition" (PN). Unfortunately, PN increases the risk of serious complications like bloodstream infection (also known as "sepsis"). For babies who are moderately premature there is little evidence to guide decision making about which babies will benefit from PN. This group of babies have more reserves of fat and are less dependent on PN, but are still at risk of sepsis. As a consequence, some doctors use PN and others do not.
AIMS
Firstly, to describe which babies are given PN during the first postnatal week in neonatal units in England, Scotland and Wales.
Secondly, to determine whether in babies born 7-10 weeks preterm (moderately premature), providing PN in the first week after birth, compared to not to providing PN, improves survival to discharge from the neonatal unit.
Finally, to evaluate if the early use of PN in moderately preterm babies affects other important outcomes in the neonatal core outcomes set.
IMPORTANCE
This work will describe the extent of PN use in England, Scotland and Wales. This is currently unknown. This project will improve understanding of the balance of benefits and harms of PN use in premature babies and will help doctors and parents make informed treatment choices.
METHODS
The investigators will use the National Neonatal Research Database (NNRD) to study all babies born in England, Scotland and Wales; they will identify which babies were given PN during the first week, and which were not. The investigators will use the NNRD to identify babies born 7-10 weeks prematurely and compare outcomes in babies that were given and not given PN in the first week after birth. The investigators will use statistical techniques to identify two sets of babies in the NNRD who are very similar (in terms of how prematurely they were born, their birth weight, and so on), the only difference being whether they were given PN or not. As the two groups will be similar any difference in their outcomes (such as survival) is likely to be due to whether or not they received PN.
Eligibility Criteria
Inclusion Criteria
Project A:
- Must be born between 1st January 2012 and 31st December 2017
- Must be admitted to a National Health Service (NHS) neonatal unit in England, Scotland or Wales
Project B:
- Must be born between 30 and 33 weeks postmenstrual age
- Must be born between 1st January 2012 and 31st December 2017
- Must be admitted to an NHS neonatal unit in England, Scotland or Wales
Exclusion Criteria
Project A:
No exclusion criteria.
Project B:
- Major congenital gastrointestinal malformations
- Life limiting conditions
- Congenital conditions requiring surgery in the neonatal period
- Missing key background data (birthweight, sex or gestational age)
- Missing data for the primary outcome
Data sourced from ClinicalTrials.gov (NCT03767634). 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.