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

Fluid Loss research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Fluid Loss

Dehydration

Extreme Immaturity

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Sterile water applicationNurses 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

ControlThe 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 washThe 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 (EnfamilĀ® 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.

Study Status

Completed

Start Date: January 2014

Completed Date: December 31, 2017

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Daily fluid intake (ml/kg/day)

Secondary Outcome: Skin Score

Study sponsors, principal investigator, and references

Principal Investigator: Mohamed El-Dib, MD

Lead Sponsor: George Washington University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02052284

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.

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