Condition category
Pregnancy and Childbirth
Date applied
23/08/2007
Date assigned
23/08/2007
Last edited
23/08/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.studies-obsgyn.nl/hypoexit.nl

Contact information

Type

Scientific

Primary contact

Ms Debbie Nuytemans

ORCID ID

Contact details

Department of Neonatology
Emma Children's Hospital
Academic Medical Centre (AMC)
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 3477
HYPO-EXIT@AMC.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ZonMW Doelmatigheid 80-007022-98-07406

Study information

Scientific title

Acronym

HYPO-EXIT

Study hypothesis

Current clinical practice varies widely, especially for infants with 'moderate' hypoglycaemia, due to lack of methodological sound studies. This leads to both over- and under-treatment of hypoglycaemic infants.

This study-protocol is directed at the comparison of two accepted management strategies at both ends of the current treatment-spectrum of moderate hypoglycaemia in 'high risk' newborns: an intensive treatment versus an expectant monitoring strategy.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Multicentre, randomised, single-blinded, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Developmental-disabilities, blood-glucose, hypoglycaemia

Intervention

In the intensive treatment arm the aim is to increase the glucose concentration above 2.5 mmol/l within three hours by increasing the carbohydrate intake by oral nutrition and/or intravenous glucose administration.

In the expectant arm the aim is to maintain the glucose concentration above 2.0 mmol/l by the usual oral nutrition protocol.

Intervention type

Drug

Phase

Not Specified

Drug names

Glucose

Primary outcome measures

Primary outcome is neurodevelopment at 18 months, assessed with the Bayley Scales of Infant Development.

Secondary outcome measures

Secondary outcomes are costs for medical treatment and hospital admission until 18 months of age.

Overall trial start date

01/10/2007

Overall trial end date

01/10/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Infants greater than or equal to 35 weeks gestational age and greater than or equal to 2000 g with one of the four major risk factors for neonatal hypoglycaemia:
1. Small-for-Gestational-Age infants (SGA, birth-weight-for-gestational-age less than P10)
2. Large-for-Gestational-Age infants (LGA, birth-weight-for-gestational-age greater than P90)
3. Near-term infants 35 0/7 to 36 6/7 weeks gestational age with a birth weight greater than 2000 g
4. Infants of Diabetic Mothers (IDM)

Birth-weight-for-gestational-age is defined according to the Kloosterman growth charts.

Participant type

Patient

Age group

Neonate

Gender

Not Specified

Target number of participants

800

Participant exclusion criteria

Infants with serious co-morbidity will be excluded, because their co-morbidity can also affect neurodevelopment:
1. Very preterm infants (less than 34 6/7 weeks gestational age)
2. Severe perinatal asphyxia - presence of at least three of the next criteria:
2.1. Signs of intrauterine asphyxia, like late decelerations on Cardiotocogram (CTG) or meconium stained amniotic fluid
2.2. Arterial umbilical cord pH less than 7.10
2.3. Delayed initiation of spontaneous respirations greater than 5 minutes after birth
2.4. Five minute Apgar score less than 5
2.5. Multi-organ failure
3. Severe perinatal infection: requiring support of vital functions (infants without clinical signs of infection who are treated with antibiotics because of suspected perinatal infection can be included)
4. Respiratory insufficiency requiring respiratory support
5. Severe hypotension requiring vasopressor support
6. (Strong suspicion of) a syndrome or major congenital malformations

Other exclusion criteria:
7. (Strong suspicion of) inborn error of metabolism
8. (Strong suspicion of) hyperinsulinism, except infants of diabetic mothers
9. No informed consent

Recruitment start date

01/10/2007

Recruitment end date

01/10/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

Department of Neonatology
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (The Netherlands)

Sponsor details

Emma Children's Hospital
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 2131
emma@amc.uva.nl

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl/

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes