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N/A N=97,507

Outcomes Following Early Parenteral Nutrition Use in Preterm Neonates

Neonatal Death · Prematurity

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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