Optimising newborn nutrition during therapeutic hypothermia

Optimising newborn nutrition during therapeutic hypothermia: An observational study using routinely collected data

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN47404296

Enrollment

7200

Registered

2017-07-24

Start date

2017-10-01

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxic-ischaemic encephalopathy requiring therapeutic hypothermia Nutritional, Metabolic, Endocrine Hypoxic-ischaemic encephalopathy requiring therapeutic hypothermia

Interventions

This study collects existing data help in the National Neonatal Research Database (NNRD). The analysis will apply the potential outcomes framework using propensity score matching. The data was collect

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Infants born at 36 gestational weeks or later 3. Received therapeutic hypothermia for Hypoxic Ischaemic Encephalopathy (HIE) for at least 72 hours 3. Died during therapeutic hypothermia

Exclusion criteria

Exclusion criteria: Infants with missing data for principal background and outcome variables. Missing values for other variables will be dealt with using multiple imputation.

Design outcomes

Primary

Measure	Time frame
1. Necrotising enterocolitis is defined using the case definition (Battersby et al 2017) between birth and final neonatal unit discharge, and is collected and analysed using the data from the NNRD 2. Blood stream infection defined as pure growth of a recognised pathogen from a normally sterile site between birth and final neonatal unit discharge, and is collected and analysed using the data NNRD	—

Secondary

Measure	Time frame
1. Survival is measured using the NNRD data between birth and neonatal unit discharge 2. Length of stay is measured using the number of days between first neonatal unit admission and final neonatal unit discharge for surviving infants using the NNRD data between birth and final neonatal unit discharge 3. Breastfeeding at discharge is measured using any breastfeeding using NNRD discharge at time of final neonatal unit discharge 4. Hypoglycaemia is measured as any diagnosis of hypoglycaemia recorded during therapeutic hypothermia and is collected and analysed using the data from the NNRD 5. Time to full feed is measured as the number of days until an infant is recorded as not requiring any parenteral nutrition or intravenous fluid between birth and final neonatal unit discharge and is collected and analysed using the data from the NNRD 6. Growth, weight and head circumference for post-menstrual age standard deviation score at final neonatal unit discharge is measured using the data from the NNRD at final neonatal unit discharge	—

Measure

Time frame

1. Survival is measured using the NNRD data between birth and neonatal unit discharge 2. Length of stay is measured using the number of days between first neonatal unit admission and final neonatal unit discharge for surviving infants using the NNRD data between birth and final neonatal unit discharge 3. Breastfeeding at discharge is measured using any breastfeeding using NNRD discharge at time of final neonatal unit discharge 4. Hypoglycaemia is measured as any diagnosis of hypoglycaemia recorded during therapeutic hypothermia and is collected and analysed using the data from the NNRD 5. Time to full feed is measured as the number of days until an infant is recorded as not requiring any parenteral nutrition or intravenous fluid between birth and final neonatal unit discharge and is collected and analysed using the data from the NNRD 6. Growth, weight and head circumference for post-menstrual age standard deviation score at final neonatal unit discharge is measured using the data from the NNRD at final neonatal unit discharge

—

Countries

England, United Kingdom

Contacts

Public ContactRichard Colquhoun

ndau@imperial.ac.uk+44 203 315 5841

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 23, 2026