|- candidate number||10390|
|- NTR Number||NTR3083|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-sep-2011|
|- Secondary IDs||N/A |
|- Public Title||Reduce heatloss in late preterms: Heated matress versus warm cot. What is the effect on body temperature and blood glucose level?|
|- Scientific Title||What is the effect of using either a heated matress or a warm cot on body temperature of late preterms (gestational age between 34 and 36 6/7 weeks) admitted to the neonatology unit at Amphia Hospital Breda in The Netherlands in the first 48 hours and what is the effect on glucose metabolism in the first 24 hours and does it influence weight development and hospital stay?|
|- hypothesis||There is no significant difference between the heated matress and warm cot as far as body temperature and glucose metabolism in late preterms are concerned.|
|- Healt Condition(s) or Problem(s) studied||Hypoglycemia, Hypothermia, Late preterms|
|- Inclusion criteria||1. Late preterm (34 0/7-36 6/7), birthweight>2000 gram;|
2. Nursery at neonatal unit;
3. Informed consent from parents.
|- Exclusion criteria||1. CPAP or mechanical respiration;|
3. Skin lesion.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||10-okt-2011|
|- planned closingdate||1-mei-2012|
|- Target number of participants||46|
|- Interventions||Randomisation between warm cot and gel-heated matresses in the first 48 hours after birth. The cot is preheated with two hot water bottles. The initial temperature of the gel-heated matress is 37.8 degrees Celcius.|
|- Primary outcome||1. Difference between two rectal temperature measurements;|
2. Blood glucose levels.
|- Secondary outcome||1. Hospital stay;|
2. Weight development.
|- Timepoints||Temperature measurement with rectal digital thermometer.|
Bed-side measurement blood glucose level with Accu-chekŪ.
T1= temp at arriving at neonatal unit;
T2= temp and glucose 1 hr. postpartum;
T3= temp and glucose 3 hrs. postpartum;
T4= temp and glucose 6 hrs. postpartum;
T5= temp and glucose 12 hrs. postpartum;
T6= temp 18 hrs. postpartum;
T7= temp and glucose 24 hrs. postpartum;
T8= temp 30 hrs. postpartum;
T9= temp 36 hrs. postpartum;
T10= temp 42 hrs. postpartum;
T11= temp 48 hrs. postpartum.
The weight development is the difference between the birth weight and the lowest body weight during hospital stay, in percentage terms.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| I. Geest, van|
|- CONTACT for SCIENTIFIC QUERIES|| I. Geest, van|
|- Sponsor/Initiator ||Master Advanced Nursing Practice, Fontys acadamy, Amphia hospital|
(Source(s) of Monetary or Material Support)
|Master Advanced Nursing Practice, Fontys acadamy, Amphia hospital|
|- Brief summary||This trial examines the differences in body temperature and glucose metabolisme between late preterms with a birth weight above 2000 grams during the first 48 hours after birth by using either a warm cot or a gel-heated matress for reducing heatloss. Secundarily this trial examines the effect of these methods on weight development and hospital stay.|
It is an randomized controlled trial, randomization by SNOSE.
|- Main changes (audit trail)|
|- RECORD||26-sep-2011 - 18-okt-2011|