Gastro-oesophageal reflux disease ( GORD ) in pre-term infants on LTHs neonatal units - Management guidelines for suspected

Publication: 19/11/2008  --
Last review: 18/11/2015  
Next review: 18/12/2021  
Clinical Guideline
CURRENT 
ID: 1403 
Approved By: Trust Clinical Guidelines Group 
Copyright© Leeds Teaching Hospitals NHS Trust 2015  

 

This Clinical Guideline is intended for use by healthcare professionals within Leeds unless otherwise stated.
For healthcare professionals in other trusts, please ensure that you consult relevant local and national guidance.

Management guidelines for suspected Gastro-oesophageal reflux disease (GORD) in pre-term infants on LTHs Neonatal units

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 How to use this guideline

Guideline summary

  • Gastro-oesophageal reflux disease (GORD) is considerably less common than simple reflux (GOR)
  • GORD is diagnosed when reflux is associated with;
    • Troublesome symptoms such as excessive crying, prolonged apnoea, etc
    • Complications such as; poor weight gain due to regurgitation/vomiting, tracheal aspiration, Oesophagitis and profound apnoeas
  • Some of the behaviour patterns recognized in term infants with GORD include 8:
    1. Vomiting and regurgitation (drooling, burping or positing)
    2. Irritability and discomfort (demonstrated by crying or frowning)
    3. Apnoea and bradycardia (particularly associated with feeds)
    4. Stretching and mouthing
    5. Yawning
    6. Stridor
  • Simple reflux (GOR) is common in healthy infants and occurs several times a day. Symptoms of reflux peak around 3-6 months of age before they spontaneously resolve by10 months of age. Simple reflux is not usually associated with cardio-respiratory events such as apnoea, bradycardia or desaturations 5,6,7 Simple reflux does not require treatment.
  • Diagnosis of GORD in pre-term infants is a difficult task. This is due to lack of a gold standard diagnostic test/s that is practical and standardized for use in pre-term infants. Symptom scores such as (Pt-GOR-Q) will assist in documenting symptoms, monitoring progression and response to treatment- appendix A.
  • Treatment of GORD in pre-term infants is complex. Careful assessment of risk to benefit ratio of the various anti-reflux therapies is required, especially that most of anti-reflux drugs are not supported by randomized controlled trials in the pre-term population. We advocate a step-wise approach to treatment Figure [2] The 2 week rule; all anti-reflux measures/drugs should be reviewed within 2 weeks, this approach is to rationalize treatment and help reduce unnecessary/prolonged prescribing of anti-reflux and allows step-down or step-up of treatment.
  • Other consideration; There is emerging evidence that Cow’s milk protein intolerance (CMPI) and GORD share symptoms profile and may indeed coexist. CMPI and a trial of cow’s milk protein (CMP) free diet may be considered in some cases of resistant GORD.Also see; Guidelines for Health Professionals in Primary Care for the Diagnosis and Management of Young Children with Cow’s Milk Intolerance and Gastro-oesophageal Reflux - PL146

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Figure [2] Inverted pyramid; hierarchy of treatment and the step-wise approach*

The Step-wise approach is based on the hierarchy of current scientific evidence. Step-1 includes treatments that are supported by randomized controlled trial in pre-term infants. Step-4 is treatments supported by expert opinion or consensus agreements. For most pre-term infants with GORD it is advisable to start at Step-1 and after a trial of at least 2 weeks (2 -week rule) treatment could be stepped-down or up if required.
It is strictly a consultant’s decision to initiate treatment at step-2 or step-3

Table1; Drug doses

GORD treatment-Drug Doses:

  1. For thickeners and formulas consult the guide to prescribing see Appendix D
  1. Ranitidine

    Enteral - Oral / Nasogastric

    <37 weeks corrected gestation - 1mg/kg twice a day
    ≥37 weeks corrected gestation - 1mg/kg three times a day
    **increase to 3mg/kg/dose if necessary**

    Slow intravenous injection
    <37 weeks corrected gestation - 0.5mg/kg twice a day
    ≥37 weeks corrected gestation - 0.5mg/kg three times a day

    Ranitidine net Formulary, Prescribing and administration
  1. Erythromycin PO 3mg/kg/QDS
  1. Omeprazole PO 0.7mg/kg/OD double dose in 1-2 weeks if no response
    Omperazole netFormulary, Prescribing and administration

Diagnosis Summary;

  • Is problematic in pre-term infants as they do not usually display classical symptoms of GORD
  • There is no single gold standard test for diagnosis of reflux in pre-term infants
  • Neonatal Reflux Score. Use of symptoms severity score (Pt-GOR-Q) score- Appendix A is a useful semi-objective tool for documenting GORD symptoms and monitoring treatment response. (Pt-GOR-Q) is a specific score for the pre-term infants developed and validated by Birch and Newell3 in collaboration with the University of Pittsburgh. It consists of 11 questions giving maximum score of 31 points. It has been validated in a small number of pre-term babies (Birch unpublished MMedSci thesis). Further validation will be undertaken on a larger number of pre-term babies).
  • Therapeutic trial. Serial observation related to introduction of treatment can be most helpful. Measures aimed at thickening milk, if beneficial should result in rapid improvement. Reduction of gastric acid production, if effective results in improvement over a few days.
  • Litmus paper test of oro-pharyngeal secretions. Is a useful bedside test but has false negatives in pre-term babies due to frequent milk feeds neutralizing gastric acid. Sensitivity 89% and specificity 80% when compared to oesophageal pH monitoring. If positive on ≥ 2 occasions has high predictive value for GORD.
  • Upper GI contrast studies should be considered prior to surgery. It is of limited value in the evaluation of GORD due to the episodic nature of the test. But it is useful in delineating oesophageal anatomy and exclusion of malrotation etc.
  • Oesophageal pH monitoring is diagnostically limited in pre-term babies due to frequent milk feeds. A major problem with oesophageal pH monitoring is its inability to detect non-acid/ weak acid episodes, which are common in pre-term babies. A combination of oesophageal pH and intraluminal impedance will detect non-acid /weakly acid reflux, however this is technically difficult and only available in research and specialist centres.
  • In the infant with Acute Life Threatening Events which may be related to GOR, or in those where surgery may be considered, investigation and therapeutic trial should be planned around the individual infant by the multidisciplinary team.
  • This guideline includes a clinical classification of GORD entities to help guide management decisions. We recommend identifying the clinical entity of GORD prior to initiation or step-up of treatment- Appendix B

Treatment summary; See figures [1] & [2]

  • In most infants GORD symptoms are well controlled by simple measures such as modification of feed volume/frequency (step-1) and/ or addition of a thickener (step-2)
  • Given the risk of sudden infant death syndrome (SIDS), prone positioning should ONLY be used in monitored infants in NNU. Pre-term infants when awake in the postprandial period, can be positioned prone or left lateral, this was shown to reduce visible regurgitation.
  • Acid suppression should be reserved for infants with symptoms suggestive of Oesophagitis. Acid suppression of the pre-term gut affects gut flora and is associated with sepsis and NEC.
    Notice: acid suppression will reduce the effectiveness of anti-regurgitant formula (e.g Enfamil AR ) and both agents should not be used in combination
  • A trial of anti-regurgitant (AR) or cow’s milk protein (CMP) free formula may be considered in infants with GORD who are approaching 37 weeks of corrected gestation and / or weigh of 2.5 kg.
  • Surgery is indicated in severe refractory GORD when symptoms fail to respond to medical treatment (chronic relapsing GORD) or in infants with severe pulmonary aspiration, growth failure or oesophageal stricture.

GORD treatment, the Evidence base;

  • Currently there is scientific evidence in the literature to support;
    1. Alteration of body position in monitored patients
    2. Addition of thickeners or change to a pre-thickened milk formula
    3. Limited trial of acid suppression
  • On the other hand, evidence is less strong in support of:
    1. Erythromycin
    2. Domperidone
    3. NJ feeding
    4. Surgical treatment
  • We used an inverted pyramid of evidence to illustrate the step-wise approach to treatment based on hierarchy of evidence as discussed in the paper of Newell and Birch 3 See Appendix C

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Provenance

Record: 1403
Objective:
  1. To emphasise the difference between GORD and simple reflux
  2. To provide a step-wise approach for treatment of GORD
  3. To help reduce unnecessary prescribing of anti reflux drugs for infants with simple reflux
  4. To help reduce unnecessary feeding interventions for infants with simple reflux
  5. To provide basis for audit and clinical process improvement
Clinical condition:

Gastro-oesophageal reflux disease (GORD) in pre-term infants.

Target patient group: Pre-term infants (born before 37 weeks) with suspected gastro-oesophageal reflux disease nursed on LTHs neonatal units
Target professional group(s): Secondary Care Doctors
Secondary Care Nurses
Adapted from:

Evidence base

Main references:

  1. Nelson SP, Chen EH, Syniar GM, Christoffel KK. Prevalence of symptoms of gastroesophageal reflux during infancy. A pediatric practice-based survey. Pediatric Practice Research Group. Arch Pediatr Adolesc Med. 1997 Jun; 151(6):569-72.
  2. Yvan Vandenplas Colin D. Rudolph. Pediatric Gastro-oesophageal Reflux Clinical Practice Guidelines:Joint Recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN). J Pediatr Gastroenterol Nutr, Vol. 49, No. 4, October 2009
  3. J L Birch, S J Newell. Gastrooesophageal reflux disease in pre-term infants: current management and diagnostic dilemmas. Arch Dis Child Fetal Neonatal Ed 2009;94:F379-F383
  4. Christian F. Poets. Gastroesophageal Reflux: A Critical Review of Its Role in Pre-term InfantsPediatrics2004;113;e128-e132
  5. J Di Fiore1, M Arko1, B Herynk, R Martin1 and AM Hibbs Characterization of cardiorespiratory events following gastroesophageal reflux in pre-term infants. Journal of Perinatology (2010) 30, 683–687
  6. Corinna S. Peter, Nadine Sprodowski, Bettina Bohnhorst, Juri Silny and Christian F.Poets Gastroesophageal Reflux and Apnea of Prematurity: No Temporal Relationship Pediatrics 2002;109;8-11
  7. Eva Wheatley, DO and Kathleen A. Kennedy, MD, MPH. Cross-Over Trial of Treatment for Bradycardia Attributed to Gastroesophageal Reflux in Pre-term Infants J Pediatr. 2009 October; 155(4): 516–521
  8. Feranchak A, Orenstein S, Cohn J. Behaviours associated with onset of gastraoesophageal reflux episodes in infants. Clin Pediatr, 1994;654-661.

Approved By

Trust Clinical Guidelines Group

Document history

LHP version 1.0

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