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

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.

Study Overview

• Status: Completed
• Conditions: Dehydration; Fluid Loss; Extreme Immaturity
• Intervention / Treatment: Other: Sterile water application

Detailed Description

Extremely low birth weight (ELBW) infants have significant transepidermal water loss immediately after birth. This significant fluid loss is related to proportionally large extracellular pool of fluids, the immaturity of the skin barrier, and the relatively large surface area exposed to evaporation. Water depletion in this population is associated with development of significant electrolyte imbalance in the form of hypernatremia, hyperkalemia, hyperglycemia and hyperosmolarity. In order to compensate for these losses, clinicians have to progressively increase fluid intake. Excessive fluid intake in the first days of life is associated with worsening patent ductus artriosus (PDA), necrotizing enterocolitis (NEC), bronchopulmonary dysplasia (BPD) and mortality. Also skin integrity is important to protect against skin infection and secondary sepsis. Based on recent studies and relevant data, the risk of sepsis in ELBW is up to 40% nationwide, but only about 25% at GWUH Water application is a benign treatment that is routinely applied to the skin of premature babies and was shown to decrease skin colonization. The current practice at GWUH is to clean the bodies of premature infants using a piece of damp cloth with warm water. This is performed at birth and consequently every other days. The study group will receive more frequent and standardized applications. The investigators hypothesize that application of sterile water in ELBW infants is associated with decreased fluid requirements in the first week of life. As a secondary outcome, the investigators hypothesize that sterile water application is associated with improved skin integrity, decreased incidence of BPD with no increased incidence of skin or systemic infections.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • The George Washington University Hospital NICU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 day (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Major congenital anomalies
2. Malformations or other surgical emergencies requiring immediate transfer.
3. Major skin abnormalities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 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.
Experimental: Water wash; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin Score	Neonatal Skin Condition Scale (NSCS) is a validated skin score used in the Association of Women's Health, Obstetric and Neonatal Nurses (AWHONN) and the National Association of Neonatal Nurses (NANN) neonatal skin care evidence-based practice project. Score ranges from 3 to 9, with 9 being the worse	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	Defined as PDA requiring treatment either medical or surgical	Participants will be followed for the duration of hospital stay, an expected average of 16 weeks
Incidence of NEC	Necrotizing Enterocolitis (NEC): defined as stages II or III	Participants will be followed for the duration of hospital stay, an expected average of 16 weeks
Incidence of BPD	Bronchopulmonary dysplasia (BPD), defined as O2 requirement at 36 weeks post menstrual age (PMA)	Participants will be followed for the duration of hospital stay, an expected average of 16 weeks
Length of stay (days)		Participants will be followed for the duration of hospital stay, an expected average of 16 weeks
Incidence of culture proved sepsis	Culture proved sepsis	Participants will be followed for the duration of hospital stay, an expected average of 16 weeks
Incidence of change in microbiological skin colonization	Change in microbiological skin colonization by skin swab between day one and day 7 of life.	First week of life

Collaborators and Investigators

• Sponsor: George Washington University
• Investigators: Principal Investigator: Mohamed El-Dib, MD, The George Washington University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: January 24, 2014
• First Submitted That Met QC Criteria: January 31, 2014
• First Posted (Estimate): February 3, 2014

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 18, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: skin; neonate; premature; ELBW; water loss
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Body Weight; Water-Electrolyte Imbalance; Birth Weight; Dehydration
• Other Study ID Numbers: 071319