Trial Outcomes & Findings for Fluid Management in Transient Tachypnea of the Newborn (NCT NCT01225029)

NCT ID: NCT01225029

Last Updated: 2013-11-28

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 64 participants
• Primary outcome timeframe: every hour until patient stable without respiratory support, an average of approximately 55 hours and a maximum of 205 hours
• Results posted on: 2013-11-28

Participant Flow

Patients were recruited at our urban tertiary care center from August 1, 2008 through September 2, 2010. Patients were withdrawn from the study protocol if any respiratory diagnosis other than TTN was made.

73 patients met enrollment criteria, and the parents of 67 eligible neonates agreed to participate. 34 were assigned to standard-of-care fluid management and 33 were assigned to the restricted fluid protocol. 2 patients from the standard fluid group and 1 patient from the restricted fluid group were withdrawn for a non-TTN respiratory diagnosis.

Participant milestones

Measure	Standard Fluids Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.	Restricted Fluids Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
Overall Study STARTED	32	32
Overall Study COMPLETED	32	32
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fluid Management in Transient Tachypnea of the Newborn

Baseline characteristics by cohort

Measure	Standard Fluids n=32 Participants Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.	Restricted Fluids n=32 Participants Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved	Total n=64 Participants Total of all reporting groups
Age, Customized	35.8 weeks STANDARD_DEVIATION 1.6 • n=5 Participants	36.4 weeks STANDARD_DEVIATION 1.5 • n=7 Participants	36.1 weeks STANDARD_DEVIATION 1.5 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: every hour until patient stable without respiratory support, an average of approximately 55 hours and a maximum of 205 hours

Outcome measures

Measure	Standard Fluids n=32 Participants Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.	Restricted Fluids n=32 Participants Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
Duration of Respiratory Support	45 hours Interval 26.0 to 85.0	42 hours Interval 26.0 to 69.0

SECONDARY outcome

Timeframe: every day until discharge, an average of approximately 8 days and a maximum of 12 days

Outcome measures

Measure	Standard Fluids n=32 Participants Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.	Restricted Fluids n=32 Participants Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
Duration of ICU Admission	8 calendar days Interval 5.0 to 12.0	7 calendar days Interval 4.0 to 10.0

SECONDARY outcome

Timeframe: hour until first enteral feed achieved, an average of approximately 40 hours and a maximum of 100 hours

Outcome measures

Measure	Standard Fluids n=32 Participants Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.	Restricted Fluids n=32 Participants Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
Time to First Enteral Feed	31 hours Interval 21.0 to 51.0	35 hours Interval 23.0 to 44.0

Adverse Events

Standard Fluids

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Restricted Fluids

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Annemarie Stroustrup

Icahn School of Medicine at Mount Sinai

Phone: 212-241-6186

Email: annemarie.stroustrup@mssm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place