PMID- 17586184
OWN - NLM
STAT- MEDLINE
DCOM- 20070723
LR  - 20220125
IS  - 1097-6833 (Electronic)
IS  - 0022-3476 (Print)
IS  - 0022-3476 (Linking)
VI  - 151
IP  - 1
DP  - 2007 Jul
TI  - Neurodevelopmental outcomes of premature infants with severe respiratory failure 
      enrolled in a randomized controlled trial of inhaled nitric oxide.
PG  - 16-22, 22.e1-3
AB  - OBJECTIVES: We hypothesized that inhaled nitric oxide (iNO) would not decrease 
      death or neurodevelopmental impairment (NDI) in infants enrolled in the National 
      Institute of Child Health and Human Development Preemie iNO Trial (PiNO) trial, 
      nor improve neurodevelopmental outcomes in the follow-up group. STUDY DESIGN: 
      Infants <34 weeks of age, weighing <1500 g, with severe respiratory failure were 
      enrolled in the multicenter, randomized, controlled trial. NDI at 18 to 22 months 
      corrected age was defined as: moderate to severe cerebral palsy (CP; Mental 
      Developmental Index or Psychomotor score Developmental Index <70), blindness, or 
      deafness. RESULTS: Of 420 patients enrolled, 109 who received iNO (52%) and 98 
      who received placebo (47%) died. The follow-up rate in survivors was 90%. iNO did 
      not reduce death or NDI (78% versus 73%; relative risk [RR], 1.07; 95% CI, 
      0.95-1.19), or NDI or Mental Developmental Index <70 in the follow-up group. 
      Moderate-severe CP was slightly higher with iNO (RR, 2.41; 95% CI, 1.01-5.75), as 
      was death or CP in infants weighing <1000 g (RR, 1.22; 95% CI, 1.05-1.43). 
      CONCLUSIONS: In this extremely ill cohort, iNO did not reduce death or NDI or 
      improve neurodevelopmental outcomes. Routine iNO use in premature infants should 
      be limited to research settings until further data are available.
FAU - Hintz, Susan R
AU  - Hintz SR
AD  - NICHD Neonatal Research Network. srhintz@stanford.edu
FAU - Van Meurs, Krisa P
AU  - Van Meurs KP
FAU - Perritt, R
AU  - Perritt R
FAU - Poole, W Kenneth
AU  - Poole WK
FAU - Das, Abhik
AU  - Das A
FAU - Stevenson, David K
AU  - Stevenson DK
FAU - Ehrenkranz, Richard A
AU  - Ehrenkranz RA
FAU - Lemons, James A
AU  - Lemons JA
FAU - Vohr, Betty R
AU  - Vohr BR
FAU - Heyne, Roy
AU  - Heyne R
FAU - Childers, David O
AU  - Childers DO
FAU - Peralta-Carcelen, Myriam
AU  - Peralta-Carcelen M
FAU - Dusick, Anna
AU  - Dusick A
FAU - Johnson, Yvette R
AU  - Johnson YR
FAU - Morris, Brenda
AU  - Morris B
FAU - Dillard, Robert
AU  - Dillard R
FAU - Vaucher, Yvonne
AU  - Vaucher Y
FAU - Steichen, Jean
AU  - Steichen J
FAU - Adams-Chapman, Ira
AU  - Adams-Chapman I
FAU - Konduri, Ganesh
AU  - Konduri G
FAU - Myers, Gary J
AU  - Myers GJ
FAU - de Ungria, Marissa
AU  - de Ungria M
FAU - Tyson, Jon E
AU  - Tyson JE
FAU - Higgins, Rosemary D
AU  - Higgins RD
CN  - NICHD Neonatal Research Network
LA  - eng
GR  - U01 HD036790/HD/NICHD NIH HHS/United States
GR  - U10 HD040498-05/HD/NICHD NIH HHS/United States
GR  - M01 RR000044-430747/RR/NCRR NIH HHS/United States
GR  - U10 HD040689/HD/NICHD NIH HHS/United States
GR  - U10 HD027904-15S2/HD/NICHD NIH HHS/United States
GR  - U10 HD027904/HD/NICHD NIH HHS/United States
GR  - U10 HD027851/HD/NICHD NIH HHS/United States
GR  - U10 HD034216-11/HD/NICHD NIH HHS/United States
GR  - M01 RR000070/RR/NCRR NIH HHS/United States
GR  - U10 HD034216/HD/NICHD NIH HHS/United States
GR  - U10 HD040498/HD/NICHD NIH HHS/United States
GR  - U10 HD027880-16/HD/NICHD NIH HHS/United States
GR  - U10 HD040461-05/HD/NICHD NIH HHS/United States
GR  - U10 HD027856/HD/NICHD NIH HHS/United States
GR  - U10 HD021373/HD/NICHD NIH HHS/United States
GR  - U10 HD040689-02/HD/NICHD NIH HHS/United States
GR  - U10 HD021385/HD/NICHD NIH HHS/United States
GR  - U10 HD027856-15/HD/NICHD NIH HHS/United States
GR  - M01 RR008084-13/RR/NCRR NIH HHS/United States
GR  - U10 HD027851-16/HD/NICHD NIH HHS/United States
GR  - M01 RR000750-330837/RR/NCRR NIH HHS/United States
GR  - U10 HD021373-22/HD/NICHD NIH HHS/United States
GR  - U10 HD027871-17/HD/NICHD NIH HHS/United States
GR  - U10 HD027853-15/HD/NICHD NIH HHS/United States
GR  - U10 HD027880/HD/NICHD NIH HHS/United States
GR  - U10 HD040521/HD/NICHD NIH HHS/United States
GR  - U10 HD040461/HD/NICHD NIH HHS/United States
GR  - M01 RR000044/RR/NCRR NIH HHS/United States
GR  - M01 RR006022-14/RR/NCRR NIH HHS/United States
GR  - UG1 HD034216/HD/NICHD NIH HHS/United States
GR  - UG1 HD027880/HD/NICHD NIH HHS/United States
GR  - M01 RR000070-445286/RR/NCRR NIH HHS/United States
GR  - U10 HD040521-05/HD/NICHD NIH HHS/United States
GR  - U01 HD036790-07/HD/NICHD NIH HHS/United States
GR  - U10 HD021385-21/HD/NICHD NIH HHS/United States
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Pediatr
JT  - The Journal of pediatrics
JID - 0375410
RN  - 31C4KY9ESH (Nitric Oxide)
SB  - IM
MH  - Administration, Inhalation
MH  - Chi-Square Distribution
MH  - Child Development/drug effects
MH  - Developmental Disabilities/prevention & control
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Infant, Newborn
MH  - *Infant, Premature
MH  - Male
MH  - Nervous System/drug effects/*growth & development
MH  - Nitric Oxide/*administration & dosage
MH  - Poisson Distribution
MH  - Respiratory Distress Syndrome, Newborn/diagnosis/*drug therapy/*mortality
MH  - Risk Assessment
MH  - Severity of Illness Index
MH  - Statistics, Nonparametric
MH  - Survival Rate
MH  - Treatment Outcome
PMC - PMC2770191
MID - NIHMS26414
EDAT- 2007/06/26 09:00
MHDA- 2007/07/24 09:00
PMCR- 2009/10/29
CRDT- 2007/06/26 09:00
PHST- 2006/09/14 00:00 [received]
PHST- 2007/01/09 00:00 [revised]
PHST- 2007/03/12 00:00 [accepted]
PHST- 2007/06/26 09:00 [pubmed]
PHST- 2007/07/24 09:00 [medline]
PHST- 2007/06/26 09:00 [entrez]
PHST- 2009/10/29 00:00 [pmc-release]
AID - S0022-3476(07)00255-7 [pii]
AID - 10.1016/j.jpeds.2007.03.017 [doi]
PST - ppublish
SO  - J Pediatr. 2007 Jul;151(1):16-22, 22.e1-3. doi: 10.1016/j.jpeds.2007.03.017.