Early inhaled nitric oxide therapy for term and near-term newborn infants with hypoxic respiratory failure: neurodevelopmental follow-up.
OBJECTIVE
To report the neurodevelopmental outcome of infants enrolled in a randomized multicenter trial of early inhaled nitric oxide (iNO) in term and near-term neonates with hypoxic respiratory failure and pulmonary hypertension.


METHODS
Neonates born at > or = 34 weeks gestation who required assisted ventilation and had an oxygenation index > or = 15 and < 25 were randomized to an early iNO group or a control group. A comprehensive neurodevelopmental assessment of survivors was performed at age 18 to 24 months.


RESULTS
The trial enrolled 299 infants, of which 266 (89%) survived to age 18 to 24 months (136 in the early iNO group and 130 in the control group). Follow-up evaluations were done on 234 (88%) of surviving infants. There were no differences between the 2 groups in the incidence of neurodevelopmental impairment (early iNO, 27%; control, 25%) and hearing impairment (early iNO, 23%; control, 24%). Mental development index scores were similar in the 2 groups; however, psychomotor developmental index scores were significantly higher in the control group (early iNO, 89 +/- 17.7; control, 93.5 +/- 18.4).


CONCLUSIONS
Early iNO therapy for hypoxic respiratory failure in term and near-term infants is not associated with an increase in neurodevelopmental impairment or hearing loss at 18 to 24 months postnatal age.
Konduri
G Ganesh
GG
Medical College of WI, Dept of Pediatrics and the Children's Research Institute, Milwaukee, WI 53201-1997, USA. gkonduri@mcw.edu
Vohr
Betty
B
Robertson
Charlene
C
Sokol
Gregory M
GM
Solimano
Alfonso
A
Singer
Joel
J
Ehrenkranz
Richard A
RA
Singhal
Nalini
N
Wright
Linda L
LL
Van Meurs
Krisa
K
Stork
Eileen
E
Kirpalani
Haresh
H
Peliowski
Abraham
A
Johnson
Yvette
Y
D000280:Administration, Inhalation; D002490:Central Nervous System / Q000254:growth & development; D016001:Confidence Intervals; D002658:Developmental Disabilities / Q000175:diagnosis*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005865:Gestational Age; D006801:Humans; D015994:Incidence; D007223:Infant; D007231:Infant, Newborn; D007234:Infant, Premature; D008297:Male; D009569:Nitric Oxide / Q000627:therapeutic use*; D011336:Probability; D011446:Prospective Studies; D012016:Reference Values; D012127:Respiratory Distress Syndrome, Newborn / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D018570:Risk Assessment; D012720:Severity of Illness Index; D015996:Survival Rate; D047929:Term Birth; D016896:Treatment Outcome
D009569:Nitric Oxide