TY - JOUR
T1 - Treatment thresholds for intervention in posthaemorrhagic ventricular dilation
T2 - A randomised controlled trial
AU - De Vries, Linda S.
AU - Groenendaal, Floris
AU - Liem, Kian D.
AU - Heep, Axel
AU - Brouwer, Annemieke J.
AU - Van 'T Verlaat, Ellen
AU - Benavente-Fernández, Isabel
AU - Van Straaten, Henrica Lm
AU - Van Wezel-Meijler, Gerda
AU - Smit, Bert J.
AU - Govaert, Paul
AU - Woerdeman, Peter A.
AU - Whitelaw, Andrew
PY - 2019/1
Y1 - 2019/1
N2 - Objective To compare a low versus a higher threshold for intervention in preterm infants with posthaemorrhagic ventricular dilatation. Design Multicentre randomised controlled trial (ISRCTN43171322). Setting 14 neonatal intensive care units in six countries. Patients 126 preterm infants ≤34 weeks gestation with ventricular dilatation after grade III-IV haemorrhage were randomised to low threshold (LT) (ventricular index (VI) >p97 and anterior horn width (AHW) >6 mm) or higher threshold (HT) (VI>p97+4 mm and AHW >10 mm). Intervention Cerebrospinal fluid tapping by lumbar punctures (LPs) (max 3), followed by taps from a ventricular reservoir, to reduce VI, and eventually a ventriculoperitoneal (VP) shunt if stabilisation of the VI below the p97+4 mm did not occur. Composite main outcome measure VP shunt or death. Results 19 of 64 (30%) LT infants and 23 of 62 (37%) HT infants were shunted or died (P=0.45). A VP shunt was inserted in 12/64 (19%) in the LT and 14/62 (23%) infants in the HT group. 7/12 (58%) LT infants and 1/14 (7%) HT infants required shunt revision (P<0.01). 62 of 64 (97%) LT infants and 36 of 62 (58%) HT infants had LPs (P<0.001). Reservoirs were inserted in 40 of 64 (62%) LT infants and 27 of 62 (43%) HT infants (P<0.05). Conclusions There was no significant difference in the primary composite outcome of VP shunt placement or death in infants with posthaemorrhagic ventricular dilatation who were treated at a lower versus a higher threshold for intervention. Infants treated at the lower threshold received more invasive procedures. Assessment of neurodevelopmental outcomes will provide further important information in assessing the risks and benefits of the two treatment approaches.
AB - Objective To compare a low versus a higher threshold for intervention in preterm infants with posthaemorrhagic ventricular dilatation. Design Multicentre randomised controlled trial (ISRCTN43171322). Setting 14 neonatal intensive care units in six countries. Patients 126 preterm infants ≤34 weeks gestation with ventricular dilatation after grade III-IV haemorrhage were randomised to low threshold (LT) (ventricular index (VI) >p97 and anterior horn width (AHW) >6 mm) or higher threshold (HT) (VI>p97+4 mm and AHW >10 mm). Intervention Cerebrospinal fluid tapping by lumbar punctures (LPs) (max 3), followed by taps from a ventricular reservoir, to reduce VI, and eventually a ventriculoperitoneal (VP) shunt if stabilisation of the VI below the p97+4 mm did not occur. Composite main outcome measure VP shunt or death. Results 19 of 64 (30%) LT infants and 23 of 62 (37%) HT infants were shunted or died (P=0.45). A VP shunt was inserted in 12/64 (19%) in the LT and 14/62 (23%) infants in the HT group. 7/12 (58%) LT infants and 1/14 (7%) HT infants required shunt revision (P<0.01). 62 of 64 (97%) LT infants and 36 of 62 (58%) HT infants had LPs (P<0.001). Reservoirs were inserted in 40 of 64 (62%) LT infants and 27 of 62 (43%) HT infants (P<0.05). Conclusions There was no significant difference in the primary composite outcome of VP shunt placement or death in infants with posthaemorrhagic ventricular dilatation who were treated at a lower versus a higher threshold for intervention. Infants treated at the lower threshold received more invasive procedures. Assessment of neurodevelopmental outcomes will provide further important information in assessing the risks and benefits of the two treatment approaches.
KW - imaging
KW - intraventricular haemorrhage
KW - neonatology
KW - post haemorrhagic ventricular dilatation
KW - preterm
UR - http://www.scopus.com/inward/record.url?scp=85049021878&partnerID=8YFLogxK
U2 - 10.1136/archdischild-2017-314206
DO - 10.1136/archdischild-2017-314206
M3 - Article (Academic Journal)
C2 - 29440132
AN - SCOPUS:85049021878
SN - 1359-2998
VL - 104
SP - F70-F75
JO - Archives of Disease in Childhood: Fetal and Neonatal Edition
JF - Archives of Disease in Childhood: Fetal and Neonatal Edition
IS - 1
ER -