Fluid Management in Transient Tachypnea of the Newborn

NCT01225029 | Completed Results DMC

• 1 other identifier: GCO 07-1069
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Transient tachypnea of the newborn (TTN) is a diagnosis given to infants born between 34 and 42 weeks gestation who develop difficulty breathing during the first days of life when no specific cause of the breathing difficulty can be identified. Little is known about why some babies develop TTN, and there have not been many formal studies of the best way to take care of babies with this disease. Babies with TTN get better on their own within three to five days after birth, but may require extra oxygen to breath well. Most physicians believe that the symptoms of TTN are related to poor clearance of fluid from the newborn's lungs. Babies with TTN have extra fluid visible on chest x-ray. Diuretics, medicines that can help clear extra lung fluid in adults and in babies with extra lung fluid for other reasons, do not to help babies with TTN. Babies with TTN need intravenous fluids to be healthy because they breathe too fast to be able to eat. Breastfed babies only get a very small amount of fluid in the first few days of life, as it normally takes several days for a new mother to begin producing breastmilk. No one has yet examined whether giving babies with TTN an amount of fluid similar to the small amount they would receive if they could breastfeed would help them recover from TTN faster. In this study, the investigators compare whether giving newborns "standard" intravenous fluid or amounts of intravenous fluid more close to what a breastfed baby would receive speeds recovery in newborns with TTN.

Conditions

Transient Tachypnea of the Newborn

Keywords

premature birth; late preterm birth; respiratory distress of the newborn; Transient tachypnea of the newborn

Outcome Measures

Primary Outcomes (1)

• Duration of Respiratory Support

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

Secondary Outcomes (2)

• Duration of ICU Admission

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

• Time to First Enteral Feed

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

Study Arms (2)

Standard Fluids

NO INTERVENTION

Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Preterm neonates receive total fluids of 80 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.

Restricted Fluids

EXPERIMENTAL

Term neonates receive total fluids of 40 mL/kg/day on day of life (DOL) 1. 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

Other: Amount of total fluids

Interventions

Amount of total fluids OTHER

Term neonates receive either total fluids of 60 mL/kg/day (standard) or 40 mL/kg/day (restricted) on day of life (DOL) 1. Preterm neonates receive total fluids of 80 mL/kg/day (standard) or 60 mL/kg/day (restricted) on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.

Restricted Fluids

Eligibility Criteria

• Age: Up to 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age at birth 34 and 42 weeks of gestation
• Admission to the Mount Sinai NICU during the first 24 hours of life
• Diagnosis during the first 24 hours of life of transient tachypnea of the newborn

You may not qualify if:

• Gestational age at birth less than 34 weeks or greater than 42 weeks at birth
• No diagnosis of TTN made in the first 24 hours of life
• Additional infant diagnosis of major cardiac disease
• Additional infant diagnosis of major pulmonary disease other than TTN
• Additional infant diagnosis of meconium aspiration syndrome
• Additional infant diagnosis of major congenital anomaly with potential to affect respiratory status in the neonatal period
• Additional infant diagnosis of infectious disease process potentially affecting respiratory status in the neonatal period
• Observation of thick meconium in the amniotic fluid at delivery.
• Maternal diagnosis of chorioamnionitis or other infection of the uterus or fallopian tubes pre- or peri-partum.
• Criteria for removal from the study:
• (a) Additional infant diagnosis of major cardiac, pulmonary, or other disease process potentially affecting respiratory status in the neonatal period (i.e., infection, meconium aspiration, pneumothorax, congenital anomaly) present during the study period. (b) Positive test of infection (e.g. blood, CSF, or urine culture; viral DFA; microscopy) drawn from infant at any point during the study period. (c) Maternal diagnosis of chorioamnionitis or other infection of the uterus or fallopian tubes at any point during hospital stay. (d) Objective clinical signs of dehydration: (i) Newborn urine output less than 2 mL/kg/hr over a twelve hour period at any point during the study period. (ii) Newborn serum sodium less than 130 mEq/L or greater than 150 mEq/L at any point during the study period. (iii) Newborn weight loss \>10% of birth weight at any point during the study period.
• (e) Newborn blood glucose by point-of-care testing of less than 40 mg/dL at any point during the study period. (f) Administration of exogenous surfactant at any point during the study period.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Related Publications (12)

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  PMID: 5906048 BACKGROUND

• Zanardo V, Simbi AK, Franzoi M, Solda G, Salvadori A, Trevisanuto D. Neonatal respiratory morbidity risk and mode of delivery at term: influence of timing of elective caesarean delivery. Acta Paediatr. 2004 May;93(5):643-7. doi: 10.1111/j.1651-2227.2004.tb02990.x.

  PMID: 15174788 BACKGROUND

• Riskin A, Abend-Weinger M, Riskin-Mashiah S, Kugelman A, Bader D. Cesarean section, gestational age, and transient tachypnea of the newborn: timing is the key. Am J Perinatol. 2005 Oct;22(7):377-82. doi: 10.1055/s-2005-872594.

  PMID: 16215925 BACKGROUND

• Jain L, Eaton DC. Physiology of fetal lung fluid clearance and the effect of labor. Semin Perinatol. 2006 Feb;30(1):34-43. doi: 10.1053/j.semperi.2006.01.006.

  PMID: 16549212 BACKGROUND

• Jain L, Dudell GG. Respiratory transition in infants delivered by cesarean section. Semin Perinatol. 2006 Oct;30(5):296-304. doi: 10.1053/j.semperi.2006.07.011.

  PMID: 17011402 BACKGROUND

• Demissie K, Marcella SW, Breckenridge MB, Rhoads GG. Maternal asthma and transient tachypnea of the newborn. Pediatrics. 1998 Jul;102(1 Pt 1):84-90. doi: 10.1542/peds.102.1.84.

  PMID: 9651418 BACKGROUND

• Persson B, Hanson U. Neonatal morbidities in gestational diabetes mellitus. Diabetes Care. 1998 Aug;21 Suppl 2:B79-84.

  PMID: 9704232 BACKGROUND

• Tutdibi E, Hospes B, Landmann E, Gortner L, Satar M, Yurdakok M, Dellagrammaticas H, Ors R, Ilikkan B, Ovali F, Sarman G, Kumral A, Arslanoglu S, Koc H, Yildiran A. Transient tachypnea of the newborn (TTN): a role for polymorphisms of surfactant protein B (SP-B) encoding gene? Klin Padiatr. 2003 Sep-Oct;215(5):248-52. doi: 10.1055/s-2003-42670.

  PMID: 14520584 BACKGROUND

• Adams JM, Moreno J, Reynolds K, Campbell DW IV, Smith EO, Weisman LE. Resource utilization among neonatologists in a university children's hospital. Pediatrics. 1997 Jun;99(6):E2. doi: 10.1542/peds.99.6.e2.

  PMID: 9164798 BACKGROUND

• Lewis V, Whitelaw A. Furosemide for transient tachypnea of the newborn. Cochrane Database Syst Rev. 2002;(1):CD003064. doi: 10.1002/14651858.CD003064.

  PMID: 11869651 BACKGROUND

• Neville MC, Morton J. Physiology and endocrine changes underlying human lactogenesis II. J Nutr. 2001 Nov;131(11):3005S-8S. doi: 10.1093/jn/131.11.3005S.

  PMID: 11694636 BACKGROUND

• Stroustrup A, Trasande L, Holzman IR. Randomized controlled trial of restrictive fluid management in transient tachypnea of the newborn. J Pediatr. 2012 Jan;160(1):38-43.e1. doi: 10.1016/j.jpeds.2011.06.027. Epub 2011 Aug 11.

  PMID: 21839467 DERIVED

MeSH Terms

Conditions

Transient Tachypnea of the Newborn; Premature Birth

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Tachypnea; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Limitations and Caveats

As a small, single center study, our results may not be fully generalizable to the TTN patient population in all hospital types on a national level.

Results Point of Contact

• Title: Dr. Annemarie Stroustrup
• Organization: Icahn School of Medicine at Mount Sinai

annemarie.stroustrup@mssm.edu

212-241-6186

Study Officials

• Annemarie Stroustrup, MD, MPH

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2010
• First Posted: October 20, 2010
• Study Start: June 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: November 28, 2013
• Results First Posted: November 28, 2013

Record last verified: 2013-09

Locations

US (1)