Outcomes Following Early Parenteral Nutrition Use in Preterm Neonates

NCT03767634 | Completed Results

• 1 other identifier: 18IC4724
• Study Type: observational
• Target: 97,507
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neonatal Death; Prematurity

Keywords

Preterm neonate; Parenteral nutrition

Outcome Measures

Primary Outcomes (2)

• Use of Parenteral Nutrition (Project A)

  Any use of parenteral nutrition in the first seven days of postnatal life (assessed using daily data extracted from the National Neonatal Research Database as described in the project protocol) This outcome formed part of Project A ONLY, and in keeping with the research protocol is only analysed and reported for the babies in this research arm.

  From birth until discharge home, assessed up to 1 year

• Survival to Discharge Home (Project B)

  Defined as recorded alive at final neonatal unit discharge This outcome formed part of Project B ONLY, and in keeping with the research protocol is only analysed and reported for the babies in this research arm.

  From birth until discharge home, assessed up to 1 year

Secondary Outcomes (12)

• Late Onset Sepsis (Project B)

  72 hours of postnatal life to discharge home, assessed up to 1 year

• Necrotising Enterocolitis (Project B)

  From birth until discharge home, assessed up to 1 year

• Brain Injury on Imaging (Project B)

  From birth until discharge home, assessed up to 1 year

• Retinopathy of Prematurity (Project B)

  From birth until discharge home, assessed up to 1 year

• Bronchopulmonary Dysplasia (Project B)

  From birth until discharge home, assessed up to 1 year

Study Arms (3)

Neonatal population (Project A)

Neonates born between 1st January 2012 and 31st December 2017 and admitted to a neonatal unit in England, Scotland and Wales).

No PN use (Project B)

All neonates born between 30 and 33 weeks postmenstrual age in England, Wales and Scotland and admitted to a NHS neonatal unit between 1st January 2012 and 31st December 2017 who did not receive any parenteral nutrition (for any duration, by any intravenous route) in the first seven postnatal days.

PN use (Project B)

All neonates born between 30 and 33 weeks postmenstrual age in England, Wales and Scotland and admitted to a NHS neonatal unit between 1st January 2012 and 31st December 2017 who received any parenteral nutrition (for any duration, by any intravenous route) in the first seven postnatal days.

Other: Parenteral nutrition

Interventions

Parenteral nutrition OTHER

Parenteral nutrition is the administration of an intravenous solution containing amino acids (with or without lipids) to provide nutritional support.

PN use (Project B)

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Neonates born between 1st January 2012 and 31st December 2017 and admitted to a neonatal unit in England, Scotland and Wales).

You may qualify if:

• 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

You may not qualify if:

• Project A:
• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Chelsea and Westminster Hospital

London, SW10 9NH, United Kingdom

Location

Related Publications (3)

• Webbe J, Battersby C, Longford N, Oughham K, Uthaya S, Modi N, Gale C. Use of parenteral nutrition in the first postnatal week in England and Wales: an observational study using real-world data. BMJ Paediatr Open. 2022 Aug;6(1):e001543. doi: 10.1136/bmjpo-2022-001543.

  PMID: 36053624 DERIVED

• Webbe JWH, Longford N, Battersby C, Oughham K, Uthaya SN, Modi N, Gale C. Outcomes in relation to early parenteral nutrition use in preterm neonates born between 30 and 33 weeks' gestation: a propensity score matched observational study. Arch Dis Child Fetal Neonatal Ed. 2022 Mar;107(2):131-136. doi: 10.1136/archdischild-2021-321643. Epub 2021 Sep 21.

  PMID: 34548324 DERIVED

• Webbe J, Longford N, Uthaya S, Modi N, Gale C. Outcomes following early parenteral nutrition use in preterm neonates: protocol for an observational study. BMJ Open. 2019 Jul 9;9(7):e029065. doi: 10.1136/bmjopen-2019-029065.

  PMID: 31289090 DERIVED

MeSH Terms

Conditions

Perinatal Death; Premature Birth; Hyperphagia

Interventions

Parenteral Nutrition

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Limitations and Caveats

This study was a retrospective, observational study using data held within the National Neonatal Research Database.

Results Point of Contact

• Title: Dr Chris Gale
• Organization: Imperial College London

christopher.gale@imperial.ac.uk

+44 (0)20 3315 3519

Study Officials

• Chris RK Gale, PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 6, 2018
• Study Start: January 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: August 1, 2021
• Last Updated: March 17, 2022
• Results First Posted: March 17, 2022

Record last verified: 2022-01

Locations

GB (1)