Trial Outcomes & Findings for Optimising Newborn Nutrition During Therapeutic Hypothermia. (NCT NCT03278847)
NCT ID: NCT03278847
Last Updated: 2023-09-14
Results Overview
Defined according to the case definition of Battersby et al., 2017, JAMA Pediatrics
Recruitment status
COMPLETED
Target enrollment
6030 participants
Primary outcome timeframe
From date of birth until date of final neonatal unit discharge, assessed up to 1 year
Results posted on
2023-09-14
Participant Flow
This was an observational study. 6030 babies were included in the overall study cohort and from this two pairs of matched groups were formed to examine the impact of enteral feeding during therapeutic hypothermia (two matched groups of 1618) and of parenteral nutrition during therapeutic hypothermia (two matched groups of 1240).
Participant milestones
| Measure |
Received Enteral (Milk) Feeds During Therapeutic Hypothermia
The gradual introduction of enteral (milk) feeds during therapeutic hypothermia:
* Included in this is any type of milk (e.g. expressed maternal breast milk, expressed donor breast milk and artificial formula)
* This health technology includes different routes of administering enteral feeds such as nasogastric tube (gavage feeding) and bottle
* This health technology also includes different rates of increasing enteral feeds (for example by 15ml/kg/day, by 30ml/kg/day or faster)
|
Enteral (Milk) Feeds Withheld During Therapeutic Hypothermia
Withholding enteral feeds (keeping a baby nil per os) for the duration of hypothermia.
|
Received Parenteral Nutrition During Therapeutic Hypothermia:
Administration of parenteral nutrition during therapeutic hypothermia:
* Included in this are different compositions of parenteral nutrition (for example standard, pre-prepared bags of nutrition and individually tailored parenteral nutrition)
* This health technology includes different routes of administration of parenteral nutrition such as via a peripheral intravenous cannula, percutaneous central venous catheter ('long line') or umbilical venous catheter.
* This health technology also includes different volumes of parenteral nutrition (e.g. 40ml/kg/day, 60ml/kg/day or greater).
|
Did Not Receive Parenteral Nutrition During Therapeutic Hypothermia
Received standard intravenous fluids (10% dextrose with additional electrolytes added where required) for the duration of hypothermia.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1618
|
1618
|
1240
|
1240
|
|
Overall Study
COMPLETED
|
1618
|
1618
|
1240
|
1240
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
Baseline characteristics by cohort
| Measure |
Received Enteral (Milk) Feeds During Therapeutic Hypothermia
n=1618 Participants
The gradual introduction of enteral (milk) feeds during therapeutic hypothermia:
* Included in this is any type of milk (e.g. expressed maternal breast milk, expressed donor breast milk and artificial formula)
* This health technology includes different routes of administering enteral feeds such as nasogastric tube (gavage feeding) and bottle
* This health technology also includes different rates of increasing enteral feeds (for example by 15ml/kg/day, by 30ml/kg/day or faster)
|
Enteral (Milk) Feeds Withheld During Therapeutic Hypothermia
n=1618 Participants
Withholding enteral feeds (keeping a baby nil per os) for the duration of hypothermia.
|
Received Parenteral Nutrition During Therapeutic Hypothermia:
n=1240 Participants
Administration of parenteral nutrition during therapeutic hypothermia:
* Included in this are different compositions of parenteral nutrition (for example standard, pre-prepared bags of nutrition and individually tailored parenteral nutrition)
* This health technology includes different routes of administration of parenteral nutrition such as via a peripheral intravenous cannula, percutaneous central venous catheter ('long line') or umbilical venous catheter.
* This health technology also includes different volumes of parenteral nutrition (e.g. 40ml/kg/day, 60ml/kg/day or greater).
|
Did Not Receive Parenteral Nutrition During Therapeutic Hypothermia
n=1240 Participants
Received standard intravenous fluids (10% dextrose with additional electrolytes added where required) for the duration of hypothermia.
|
Total
n=5716 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race/Ethnicity, Customized
Parenteral nutrition - White
|
—
|
—
|
991 Participants
n=1240 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
1002 Participants
n=1240 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
1993 Participants
n=2480 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
|
Race/Ethnicity, Customized
Parenteral nutrition - Asian or Mixed Asian
|
—
|
—
|
93 Participants
n=1240 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
98 Participants
n=1240 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
191 Participants
n=2480 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
|
Race/Ethnicity, Customized
Parenteral nutrition - Black or mixed black African
|
—
|
—
|
62 Participants
n=1240 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
53 Participants
n=1240 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
115 Participants
n=2480 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
|
Race/Ethnicity, Customized
Parenteral nutrition - Other and missing
|
—
|
—
|
94 Participants
n=1240 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
86 Participants
n=1240 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
180 Participants
n=2480 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=1618 Participants
|
0 participants
n=1618 Participants
|
1240 participants
n=1240 Participants
|
1240 participants
n=1240 Participants
|
2480 participants
n=5716 Participants
|
|
Cord pH <6.9
Enteral feeding
|
368 Participants
n=1618 Participants • This is a factorial study where the same babies are included in both enteral and parenteral analyses
|
368 Participants
n=1618 Participants • This is a factorial study where the same babies are included in both enteral and parenteral analyses
|
—
|
—
|
736 Participants
n=3236 Participants • This is a factorial study where the same babies are included in both enteral and parenteral analyses
|
|
Cord pH <6.9
Parenteral nutrition
|
—
|
—
|
280 Participants
n=1240 Participants • This is a factorial study where the same babies are included in both enteral and parenteral analyses
|
280 Participants
n=1240 Participants • This is a factorial study where the same babies are included in both enteral and parenteral analyses
|
560 Participants
n=2480 Participants • This is a factorial study where the same babies are included in both enteral and parenteral analyses
|
|
Apgar score 0 or 1 at 5 minutes
Enteral feeding
|
678 Participants
n=1618 Participants • This is a factorial study where the same babies are included in both enteral and parenteral analyses
|
720 Participants
n=1618 Participants • This is a factorial study where the same babies are included in both enteral and parenteral analyses
|
—
|
—
|
1398 Participants
n=3236 Participants • This is a factorial study where the same babies are included in both enteral and parenteral analyses
|
|
Apgar score 0 or 1 at 5 minutes
Parenteral nutrition
|
—
|
—
|
562 Participants
n=1240 Participants • This is a factorial study where the same babies are included in both enteral and parenteral analyses
|
553 Participants
n=1240 Participants • This is a factorial study where the same babies are included in both enteral and parenteral analyses
|
1115 Participants
n=2480 Participants • This is a factorial study where the same babies are included in both enteral and parenteral analyses
|
|
Treatment with inotropes on day of admission
Enteral feeding
|
288 Participants
n=1618 Participants • This is a factorial study and the same babies are included in both enteral and parenteral analyses
|
295 Participants
n=1618 Participants • This is a factorial study and the same babies are included in both enteral and parenteral analyses
|
—
|
—
|
583 Participants
n=3236 Participants • This is a factorial study and the same babies are included in both enteral and parenteral analyses
|
|
Treatment with inotropes on day of admission
Parenteral nutrition
|
—
|
—
|
287 Participants
n=1240 Participants • This is a factorial study and the same babies are included in both enteral and parenteral analyses
|
295 Participants
n=1240 Participants • This is a factorial study and the same babies are included in both enteral and parenteral analyses
|
582 Participants
n=2480 Participants • This is a factorial study and the same babies are included in both enteral and parenteral analyses
|
|
Age, Customized
Enteral feeding
|
39.5 Weeks
STANDARD_DEVIATION 1.5 • n=1618 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
39.5 Weeks
STANDARD_DEVIATION 1.5 • n=1618 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
—
|
—
|
39.5 Weeks
STANDARD_DEVIATION 1.5 • n=3236 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
|
Age, Customized
Parenteral feeding
|
—
|
—
|
39.4 Weeks
STANDARD_DEVIATION 1.6 • n=1240 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
39.4 Weeks
STANDARD_DEVIATION 1.6 • n=1240 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
39.4 Weeks
STANDARD_DEVIATION 1.6 • n=2480 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
|
Sex: Female, Male
Enteral feeding · Female
|
715 Participants
n=1618 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
715 Participants
n=1618 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
0 Participants
This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
0 Participants
This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
1430 Participants
n=3236 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
|
Sex: Female, Male
Enteral feeding · Male
|
903 Participants
n=1618 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
903 Participants
n=1618 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
0 Participants
This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
0 Participants
This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
1806 Participants
n=3236 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
|
Sex: Female, Male
Parenteral nutrition · Female
|
0 Participants
This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
0 Participants
This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
576 Participants
n=1240 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
588 Participants
n=1240 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
1164 Participants
n=2480 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
|
Sex: Female, Male
Parenteral nutrition · Male
|
0 Participants
This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
0 Participants
This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
664 Participants
n=1240 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
652 Participants
n=1240 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
1316 Participants
n=2480 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
|
Race/Ethnicity, Customized
Enteral feeding - White
|
1040 Participants
n=1618 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
1041 Participants
n=1618 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
—
|
—
|
2081 Participants
n=3236 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
|
Race/Ethnicity, Customized
Enteral feeding - Asian or mixed Asian
|
169 Participants
n=1618 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
174 Participants
n=1618 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
—
|
—
|
343 Participants
n=3236 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
|
Race/Ethnicity, Customized
Enteral feeding - Black or mixed black African
|
103 Participants
n=1618 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
99 Participants
n=1618 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
—
|
—
|
202 Participants
n=3236 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
|
Race/Ethnicity, Customized
Enteral feeding - Other and missing
|
306 Participants
n=1618 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
304 Participants
n=1618 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
—
|
—
|
610 Participants
n=3236 Participants • This is a factorial study where the same group of babies were included in enteral and parenteral nutrition analyses
|
PRIMARY outcome
Timeframe: From date of birth until date of final neonatal unit discharge, assessed up to 1 yearPopulation: NA indicates \<5 where the cell value is withheld to avoid identifying participants
Defined according to the case definition of Battersby et al., 2017, JAMA Pediatrics
Outcome measures
| Measure |
Received Enteral (Milk) Feeds During Therapeutic Hypothermia
n=1618 Participants
The gradual introduction of enteral (milk) feeds during therapeutic hypothermia:
* Included in this is any type of milk (e.g. expressed maternal breast milk, expressed donor breast milk and artificial formula)
* This health technology includes different routes of administering enteral feeds such as nasogastric tube (gavage feeding) and bottle
* This health technology also includes different rates of increasing enteral feeds (for example by 15ml/kg/day, by 30ml/kg/day or faster)
|
Enteral (Milk) Feeds Withheld During Therapeutic Hypothermia
n=1618 Participants
Withholding enteral feeds (keeping a baby nil per os) for the duration of hypothermia.
|
Received Parenteral Nutrition During Therapeutic Hypothermia:
n=1240 Participants
Administration of parenteral nutrition during therapeutic hypothermia:
* Included in this are different compositions of parenteral nutrition (for example standard, pre-prepared bags of nutrition and individually tailored parenteral nutrition)
* This health technology includes different routes of administration of parenteral nutrition such as via a peripheral intravenous cannula, percutaneous central venous catheter ('long line') or umbilical venous catheter.
* This health technology also includes different volumes of parenteral nutrition (e.g. 40ml/kg/day, 60ml/kg/day or greater).
|
Did Not Receive Parenteral Nutrition During Therapeutic Hypothermia
n=1240 Participants
Received standard intravenous fluids (10% dextrose with additional electrolytes added where required) for the duration of hypothermia.
|
|---|---|---|---|---|
|
Necrotising Enterocolitis - for the Enteral Nutrition Comparison
|
NA Participants
NA indicates \<5 where the cell value is withheld to avoid identifying participants
|
NA Participants
NA indicates \<5 where the cell value is withheld to avoid identifying participants
|
NA Participants
NA indicates \<5 where the cell value is withheld to avoid identifying participants
|
7 Participants
|
PRIMARY outcome
Timeframe: From date of birth until date of final neonatal unit discharge, assessed up to 1 yeardefined according to the Healthcare Quality Improvement Partnership (HQIP) National Neonatal Audit Programme (NNAP) case definition: pure growth of a recognised pathogen from a normally sterile site
Outcome measures
| Measure |
Received Enteral (Milk) Feeds During Therapeutic Hypothermia
n=1618 Participants
The gradual introduction of enteral (milk) feeds during therapeutic hypothermia:
* Included in this is any type of milk (e.g. expressed maternal breast milk, expressed donor breast milk and artificial formula)
* This health technology includes different routes of administering enteral feeds such as nasogastric tube (gavage feeding) and bottle
* This health technology also includes different rates of increasing enteral feeds (for example by 15ml/kg/day, by 30ml/kg/day or faster)
|
Enteral (Milk) Feeds Withheld During Therapeutic Hypothermia
n=1618 Participants
Withholding enteral feeds (keeping a baby nil per os) for the duration of hypothermia.
|
Received Parenteral Nutrition During Therapeutic Hypothermia:
n=1240 Participants
Administration of parenteral nutrition during therapeutic hypothermia:
* Included in this are different compositions of parenteral nutrition (for example standard, pre-prepared bags of nutrition and individually tailored parenteral nutrition)
* This health technology includes different routes of administration of parenteral nutrition such as via a peripheral intravenous cannula, percutaneous central venous catheter ('long line') or umbilical venous catheter.
* This health technology also includes different volumes of parenteral nutrition (e.g. 40ml/kg/day, 60ml/kg/day or greater).
|
Did Not Receive Parenteral Nutrition During Therapeutic Hypothermia
n=1240 Participants
Received standard intravenous fluids (10% dextrose with additional electrolytes added where required) for the duration of hypothermia.
|
|---|---|---|---|---|
|
Blood Stream Infection - for the Parenteral Nutrition Comparison
|
NA Participants
NA indicates \<5 where the cell value is withheld to avoid identifying participants
|
8 Participants
|
11 Participants
|
NA Participants
NA indicates \<5 where the cell value is withheld to avoid identifying participants
|
SECONDARY outcome
Timeframe: From date of birth until date of final neonatal unit discharge, assessed up to 1 yearSurvival at neonatal unit discharge
Outcome measures
| Measure |
Received Enteral (Milk) Feeds During Therapeutic Hypothermia
n=1618 Participants
The gradual introduction of enteral (milk) feeds during therapeutic hypothermia:
* Included in this is any type of milk (e.g. expressed maternal breast milk, expressed donor breast milk and artificial formula)
* This health technology includes different routes of administering enteral feeds such as nasogastric tube (gavage feeding) and bottle
* This health technology also includes different rates of increasing enteral feeds (for example by 15ml/kg/day, by 30ml/kg/day or faster)
|
Enteral (Milk) Feeds Withheld During Therapeutic Hypothermia
n=1618 Participants
Withholding enteral feeds (keeping a baby nil per os) for the duration of hypothermia.
|
Received Parenteral Nutrition During Therapeutic Hypothermia:
n=1240 Participants
Administration of parenteral nutrition during therapeutic hypothermia:
* Included in this are different compositions of parenteral nutrition (for example standard, pre-prepared bags of nutrition and individually tailored parenteral nutrition)
* This health technology includes different routes of administration of parenteral nutrition such as via a peripheral intravenous cannula, percutaneous central venous catheter ('long line') or umbilical venous catheter.
* This health technology also includes different volumes of parenteral nutrition (e.g. 40ml/kg/day, 60ml/kg/day or greater).
|
Did Not Receive Parenteral Nutrition During Therapeutic Hypothermia
n=1240 Participants
Received standard intravenous fluids (10% dextrose with additional electrolytes added where required) for the duration of hypothermia.
|
|---|---|---|---|---|
|
Survival
|
1552 Participants
|
1465 Participants
|
1154 Participants
|
1116 Participants
|
SECONDARY outcome
Timeframe: From date of birth until date of final neonatal unit discharge, assessed up to 1 yearNumber of days between first neonatal unit admission and final neonatal unit discharge for surviving infants
Outcome measures
| Measure |
Received Enteral (Milk) Feeds During Therapeutic Hypothermia
n=1618 Participants
The gradual introduction of enteral (milk) feeds during therapeutic hypothermia:
* Included in this is any type of milk (e.g. expressed maternal breast milk, expressed donor breast milk and artificial formula)
* This health technology includes different routes of administering enteral feeds such as nasogastric tube (gavage feeding) and bottle
* This health technology also includes different rates of increasing enteral feeds (for example by 15ml/kg/day, by 30ml/kg/day or faster)
|
Enteral (Milk) Feeds Withheld During Therapeutic Hypothermia
n=1618 Participants
Withholding enteral feeds (keeping a baby nil per os) for the duration of hypothermia.
|
Received Parenteral Nutrition During Therapeutic Hypothermia:
n=1240 Participants
Administration of parenteral nutrition during therapeutic hypothermia:
* Included in this are different compositions of parenteral nutrition (for example standard, pre-prepared bags of nutrition and individually tailored parenteral nutrition)
* This health technology includes different routes of administration of parenteral nutrition such as via a peripheral intravenous cannula, percutaneous central venous catheter ('long line') or umbilical venous catheter.
* This health technology also includes different volumes of parenteral nutrition (e.g. 40ml/kg/day, 60ml/kg/day or greater).
|
Did Not Receive Parenteral Nutrition During Therapeutic Hypothermia
n=1240 Participants
Received standard intravenous fluids (10% dextrose with additional electrolytes added where required) for the duration of hypothermia.
|
|---|---|---|---|---|
|
Length of Stay
|
12.7 Days
Interval 12.0 to 13.3
|
14.8 Days
Interval 14.2 to 15.5
|
15.0 Days
Interval 14.1 to 15.8
|
14.1 Days
Interval 13.6 to 14.7
|
SECONDARY outcome
Timeframe: At the point of final discharge from neonatal care, assessed up to 1 yearAny breastfeeding (suckling at the breast) at discharge
Outcome measures
| Measure |
Received Enteral (Milk) Feeds During Therapeutic Hypothermia
n=1618 Participants
The gradual introduction of enteral (milk) feeds during therapeutic hypothermia:
* Included in this is any type of milk (e.g. expressed maternal breast milk, expressed donor breast milk and artificial formula)
* This health technology includes different routes of administering enteral feeds such as nasogastric tube (gavage feeding) and bottle
* This health technology also includes different rates of increasing enteral feeds (for example by 15ml/kg/day, by 30ml/kg/day or faster)
|
Enteral (Milk) Feeds Withheld During Therapeutic Hypothermia
n=1618 Participants
Withholding enteral feeds (keeping a baby nil per os) for the duration of hypothermia.
|
Received Parenteral Nutrition During Therapeutic Hypothermia:
n=1240 Participants
Administration of parenteral nutrition during therapeutic hypothermia:
* Included in this are different compositions of parenteral nutrition (for example standard, pre-prepared bags of nutrition and individually tailored parenteral nutrition)
* This health technology includes different routes of administration of parenteral nutrition such as via a peripheral intravenous cannula, percutaneous central venous catheter ('long line') or umbilical venous catheter.
* This health technology also includes different volumes of parenteral nutrition (e.g. 40ml/kg/day, 60ml/kg/day or greater).
|
Did Not Receive Parenteral Nutrition During Therapeutic Hypothermia
n=1240 Participants
Received standard intravenous fluids (10% dextrose with additional electrolytes added where required) for the duration of hypothermia.
|
|---|---|---|---|---|
|
Breastfeeding
|
883 Participants
|
752 Participants
|
575 Participants
|
582 Participants
|
SECONDARY outcome
Timeframe: From date of birth until date of final neonatal unit discharge, assessed up to 1 yearAny diagnosis of hypoglycaemia recorded after therapeutic hypothermia is commenced and before the final neonatal unit discharge
Outcome measures
| Measure |
Received Enteral (Milk) Feeds During Therapeutic Hypothermia
n=1618 Participants
The gradual introduction of enteral (milk) feeds during therapeutic hypothermia:
* Included in this is any type of milk (e.g. expressed maternal breast milk, expressed donor breast milk and artificial formula)
* This health technology includes different routes of administering enteral feeds such as nasogastric tube (gavage feeding) and bottle
* This health technology also includes different rates of increasing enteral feeds (for example by 15ml/kg/day, by 30ml/kg/day or faster)
|
Enteral (Milk) Feeds Withheld During Therapeutic Hypothermia
n=1618 Participants
Withholding enteral feeds (keeping a baby nil per os) for the duration of hypothermia.
|
Received Parenteral Nutrition During Therapeutic Hypothermia:
n=1240 Participants
Administration of parenteral nutrition during therapeutic hypothermia:
* Included in this are different compositions of parenteral nutrition (for example standard, pre-prepared bags of nutrition and individually tailored parenteral nutrition)
* This health technology includes different routes of administration of parenteral nutrition such as via a peripheral intravenous cannula, percutaneous central venous catheter ('long line') or umbilical venous catheter.
* This health technology also includes different volumes of parenteral nutrition (e.g. 40ml/kg/day, 60ml/kg/day or greater).
|
Did Not Receive Parenteral Nutrition During Therapeutic Hypothermia
n=1240 Participants
Received standard intravenous fluids (10% dextrose with additional electrolytes added where required) for the duration of hypothermia.
|
|---|---|---|---|---|
|
Hypoglycaemia
|
293 Participants
|
269 Participants
|
212 Participants
|
235 Participants
|
SECONDARY outcome
Timeframe: From date of birth until date of final neonatal unit discharge, assessed up to 1 yearThe number of days until an infant is recorded as not having a central venous line
Outcome measures
| Measure |
Received Enteral (Milk) Feeds During Therapeutic Hypothermia
n=1618 Participants
The gradual introduction of enteral (milk) feeds during therapeutic hypothermia:
* Included in this is any type of milk (e.g. expressed maternal breast milk, expressed donor breast milk and artificial formula)
* This health technology includes different routes of administering enteral feeds such as nasogastric tube (gavage feeding) and bottle
* This health technology also includes different rates of increasing enteral feeds (for example by 15ml/kg/day, by 30ml/kg/day or faster)
|
Enteral (Milk) Feeds Withheld During Therapeutic Hypothermia
n=1618 Participants
Withholding enteral feeds (keeping a baby nil per os) for the duration of hypothermia.
|
Received Parenteral Nutrition During Therapeutic Hypothermia:
n=1240 Participants
Administration of parenteral nutrition during therapeutic hypothermia:
* Included in this are different compositions of parenteral nutrition (for example standard, pre-prepared bags of nutrition and individually tailored parenteral nutrition)
* This health technology includes different routes of administration of parenteral nutrition such as via a peripheral intravenous cannula, percutaneous central venous catheter ('long line') or umbilical venous catheter.
* This health technology also includes different volumes of parenteral nutrition (e.g. 40ml/kg/day, 60ml/kg/day or greater).
|
Did Not Receive Parenteral Nutrition During Therapeutic Hypothermia
n=1240 Participants
Received standard intravenous fluids (10% dextrose with additional electrolytes added where required) for the duration of hypothermia.
|
|---|---|---|---|---|
|
Duration of Central Venous Line
|
4.3 Days
Interval 4.1 to 4.5
|
5.5 Days
Interval 5.3 to 5.7
|
6 Days
Interval 5.7 to 6.3
|
5.1 Days
Interval 5.0 to 5.3
|
SECONDARY outcome
Timeframe: From date of birth until date of final neonatal unit discharge, assessed up to 1 yearWeight for post-menstrual age standard deviation score at final neonatal unit discharge. Standard deviation score, higher score means higher growth (higher weight for gestational age)
Outcome measures
| Measure |
Received Enteral (Milk) Feeds During Therapeutic Hypothermia
n=1618 Participants
The gradual introduction of enteral (milk) feeds during therapeutic hypothermia:
* Included in this is any type of milk (e.g. expressed maternal breast milk, expressed donor breast milk and artificial formula)
* This health technology includes different routes of administering enteral feeds such as nasogastric tube (gavage feeding) and bottle
* This health technology also includes different rates of increasing enteral feeds (for example by 15ml/kg/day, by 30ml/kg/day or faster)
|
Enteral (Milk) Feeds Withheld During Therapeutic Hypothermia
n=1618 Participants
Withholding enteral feeds (keeping a baby nil per os) for the duration of hypothermia.
|
Received Parenteral Nutrition During Therapeutic Hypothermia:
n=1240 Participants
Administration of parenteral nutrition during therapeutic hypothermia:
* Included in this are different compositions of parenteral nutrition (for example standard, pre-prepared bags of nutrition and individually tailored parenteral nutrition)
* This health technology includes different routes of administration of parenteral nutrition such as via a peripheral intravenous cannula, percutaneous central venous catheter ('long line') or umbilical venous catheter.
* This health technology also includes different volumes of parenteral nutrition (e.g. 40ml/kg/day, 60ml/kg/day or greater).
|
Did Not Receive Parenteral Nutrition During Therapeutic Hypothermia
n=1240 Participants
Received standard intravenous fluids (10% dextrose with additional electrolytes added where required) for the duration of hypothermia.
|
|---|---|---|---|---|
|
Growth
|
-0.54 Standard deviation score
Interval -0.59 to -0.48
|
-0.6 Standard deviation score
Interval -0.65 to -0.55
|
-0.65 Standard deviation score
Interval -0.71 to -0.58
|
-0.66 Standard deviation score
Interval -0.71 to -0.61
|
Adverse Events
Received Enteral (Milk) Feeds During Therapeutic Hypothermia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 66 deaths
Enteral (Milk) Feeds Withheld During Therapeutic Hypothermia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 153 deaths
Received Parenteral Nutrition During Therapeutic Hypothermia:
Serious events: 0 serious events
Other events: 0 other events
Deaths: 86 deaths
Did Not Receive Parenteral Nutrition During Therapeutic Hypothermia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 124 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Chris Gale, Reader in Neonatal Medicine
Imperial College London
Phone: +44 203 3153519
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place