Clinical trial NCT02052284: The Application of Sterile Water to the Skin of Extremely Low Birth Weight (ELBW) Infants
Official title: The Application of Sterile Water to the Skin of Extremely Low Birth Weight (ELBW) Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fluid Loss
Dehydration
Extreme Immaturity
Keywords: ELBW
premature
neonate
skin
water loss
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2014-02-03
Enrollment: 30
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Daily fluid intake (ml/kg/day)
timeFrame: First 7 days of life
Secondary outcomes:
measure: Skin Score
timeFrame: First 7 days of life
measure: Peak total bilirubin (mg/dl)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 16 weeks
measure: Incidence of significant PDA
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 16 weeks
measure: Incidence of NEC
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 16 weeks
measure: Incidence of BPD
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 16 weeks
measure: Length of stay (days)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 16 weeks
measure: Incidence of culture proved sepsis
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 16 weeks
measure: Incidence of change in microbiological skin colonization
timeFrame: First week of life
Other outcomes:
Locations:
city: Washington
country: United States
facility: The George Washington University Hospital NICU
state: District of Columbia
Study officials:
affiliation: The George Washington University
name: Mohamed El-Dib, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.