Perineuraxial Anesthesia Fluid Management and Infant Neurobehaviors (PAFUMIN)

This study has been completed.
Sponsor:
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00987701
First received: September 30, 2009
Last updated: July 26, 2011
Last verified: July 2011

September 30, 2009
July 26, 2011
September 2009
May 2011   (final data collection date for primary outcome measure)
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) [ Time Frame: Immediate after birth (0 min) ] [ Designated as safety issue: Yes ]
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) [ Time Frame: Immediate after birth (0 min), 30min, 2h, 4h, 12h, 24h, 2d, 1wk, 1month, and 6months after birth. ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00987701 on ClinicalTrials.gov Archive Site
  • Apgar scoring [ Time Frame: One min and 5min after birth. ] [ Designated as safety issue: Yes ]
  • Umbilical-cord gases analysis [ Time Frame: At the time baby was born (0min) ] [ Designated as safety issue: Yes ]
  • Neonatal sepsis evaluation [ Time Frame: One hour after the baby was born ] [ Designated as safety issue: Yes ]
  • Neonatal antibiotic treatment [ Time Frame: One hour after the baby was born ] [ Designated as safety issue: Yes ]
  • Incidence of maternal side effects [ Time Frame: Analgesia initiation (0min) to successful vaginal delivery (this time encountered alteration with different women) ] [ Designated as safety issue: Yes ]
  • Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) [ Time Frame: 30min after birth ] [ Designated as safety issue: Yes ]
  • Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) [ Time Frame: 1h after birth ] [ Designated as safety issue: Yes ]
  • Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) [ Time Frame: 8h after birth ] [ Designated as safety issue: Yes ]
  • Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) [ Time Frame: 1d after birth ] [ Designated as safety issue: Yes ]
  • Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) [ Time Frame: 1wk after birth ] [ Designated as safety issue: Yes ]
  • Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) [ Time Frame: 1month after birth ] [ Designated as safety issue: Yes ]
  • Apgar scoring [ Time Frame: One min and 5min after birth. ] [ Designated as safety issue: Yes ]
  • Umbilical-cord gases analysis [ Time Frame: At the time baby was born (0min) ] [ Designated as safety issue: Yes ]
  • Neonatal sepsis evaluation [ Time Frame: One hour after the baby was born ] [ Designated as safety issue: Yes ]
  • Neonatal antibiotic treatment [ Time Frame: One hour after the baby was born ] [ Designated as safety issue: Yes ]
  • Incidence of maternal side effects [ Time Frame: Analgesia initiation (0min) to successful vaginal delivery (this time encountered alteration with different women) ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Perineuraxial Anesthesia Fluid Management and Infant Neurobehaviors
Correlation Between Perineuraxial Anesthesia Fluid Resuscitation in Cesarean Section and Infant Neurobehaviors

Early change in neurobehavior is strongly associated with the intelligence development of children. Previous studies reported that cesarean section itself could influence the later development of children. In addition, neuraxial anesthesia including epidural, spinal and combined spinal epidural anesthesia (CSEA) are the major forms used during cesarean delivery, and these anesthesia techniques will undoubtedly evoke hypotension and corresponding hemodynamic alteration, of which would result in decreasing in umbilical placental insufficiency and fetus hypoxia leading to early abnormality of neurobehaviors in infants. Fluid management, such as crystalloid and colloid, is the common ones given before or / and after neuraxial anesthesia to prevent or reverse hypotension. However, it is still unknown whether the perineuraxial anesthesia fluid resuscitation could improve the neurobehavior scorings, and could produce positive effect on later intelligence development. Herein the investigators hypothesized that effective perineuraxial anesthesia fluid management during cesarean section would prevent the occurrence of hypotension and improve infant's neurobehavior scorings.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Cesarean Section
  • Drug: Ringer's Lactate
    Ringer's Lactate 8 ml/kg was given intravenously before or after epidural, spinal or CSEA in cesarean section
    Other Name: Lactated Ringer's solution
  • Drug: Six percent hydroxyethyl starch
    Hydroxyethyl starch (6%) was given before or after epidural, spinal or CSEA in cesarean section
    Other Name: HES/HAES
  • Active Comparator: Crystalloid resuscitation
    Crystalloid (Ringer's lactate) will be delivered before (15min) or after (15min) neuraxial anesthesia
    Intervention: Drug: Ringer's Lactate
  • Active Comparator: Colloid resuscitation
    Colloid (6% hydroxyethyl starch ) will be delivered before (15min) or after (15min) neuraxial anesthesia
    Intervention: Drug: Six percent hydroxyethyl starch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5000
May 2011
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 21-40 yr
  • First time of delivery
  • ASA status I-II
  • No premature
  • No genetic and infectious diseases
  • Chinese

Exclusion Criteria:

  • < 21 yr
  • > 40 yr
  • Subjects with cardiac and pulmonary disorders
  • Dislocation of placenta
  • Pregnant hypertension
  • Allergy to local anesthetics
  • Unwilling to cooperation
  • With significant delivery side effects
Female
21 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00987701
NJMU-0932MZ, NMUK2190
Yes
XiaoFeng Shen, Nanjing Medical University
Nanjing Medical University
Not Provided
Study Chair: XiaoFeng Shen, MD Nanjing Medical University
Nanjing Medical University
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP