The Application of Sterile Water to the Skin of Extremely Low Birth Weight (ELBW) Infants

NCT02052284 | Completed

• 1 other identifier: 071319
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Extremely low birth weight infants have significant water loss through their skin immediately after birth. This significant fluid loss is because they have large amounts of fluids, have immature skin and large surface area. Loss of fluids is associated with many complications. The investigators hypothesize that application of sterile water to the skin of these infants is associated with decreased fluid requirements in the first week of life , improve skin integrity and decrease some complications of prematurity.

Conditions

Fluid Loss; Dehydration; Extreme Immaturity

Keywords

ELBW; premature; neonate; skin; water loss

Outcome Measures

Primary Outcomes (1)

• Daily fluid intake (ml/kg/day)

  The primary outcome is daily fluid requirements in the first week of life. Daily fluid requirements from Day1 to Day7 will be compared between intervention and control groups.

  First 7 days of life

Secondary Outcomes (8)

• Skin Score

  First 7 days of life

• Peak total bilirubin (mg/dl)

  Participants will be followed for the duration of hospital stay, an expected average of 16 weeks

• Incidence of significant PDA

  Participants will be followed for the duration of hospital stay, an expected average of 16 weeks

• Incidence of NEC

  Participants will be followed for the duration of hospital stay, an expected average of 16 weeks

• Incidence of BPD

  Participants will be followed for the duration of hospital stay, an expected average of 16 weeks

Study Arms (2)

Control

NO INTERVENTION

The control group will receive standard skin care of the NICU, which does not include specific measures to modulate skin-barrier function.The current practice at GWUH NICU is that nurses clean the bodies of newborns less than 1000 grams using a piece of damp cloth with warm water. This is performed at birth and consequently every other days.

Water wash

EXPERIMENTAL

The study group will undergo a protocol of sterile water application in addition to routine skin care of the NICU. The study group will receive more frequent and standardized applications. A commercially sterile water bottle (Enfamil® Water) will be kept inside the isolette, to be maintained at isolette temperature, and will be changed on a daily basis. Nurses use sterile gloves as a routine for care of ELBW infants. A 2 inches x 2 inches sterile gauze will be soaked in sterile water and gently applied to all skin of the baby excluding umbilical cord and IV lines sites. This procedure will be repeated every 4 hours with routine patient care for the first 1 week of life.

Other: Sterile water application

Interventions

Sterile water application OTHER

Nurses are trained in proper dispensing and application of water in a sterile gentle way that will minimize shear force on the skin, risk for skin injury, and the potential for spread of fecal flora.

Water wash

Eligibility Criteria

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

You may qualify if:

• Extremely Low Birth Weight (less than 1000 grams at birth), and
• Less than 24 hours of life

You may not qualify if:

• Major congenital anomalies
• Malformations or other surgical emergencies requiring immediate transfer.
• Major skin abnormalities

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

The George Washington University Hospital NICU

Washington D.C., District of Columbia, 20037, United States

Location

Related Publications (3)

• Baumgart S, Langman CB, Sosulski R, Fox WW, Polin RA. Fluid, electrolyte, and glucose maintenance in the very low birth weight infant. Clin Pediatr (Phila). 1982 Apr;21(4):199-206. doi: 10.1177/000992288202100401.

  PMID: 7067312 BACKGROUND

• Afsar FS. Physiological skin conditions of preterm and term neonates. Clin Exp Dermatol. 2010 Jun;35(4):346-50. doi: 10.1111/j.1365-2230.2009.03562.x. Epub 2009 Sep 15.

  PMID: 19758381 BACKGROUND

• Bell EF, Acarregui MJ. Restricted versus liberal water intake for preventing morbidity and mortality in preterm infants. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD000503. doi: 10.1002/14651858.CD000503.pub2.

  PMID: 18253981 BACKGROUND

MeSH Terms

Conditions

Dehydration; Premature Birth

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Mohamed El-Dib, MD

  The George Washington University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics and of Neurology

Study Record Dates

• First Submitted: January 24, 2014
• First Posted: February 3, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 31, 2017
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

US (1)