Consent

FOR COMMON NEONATAL INVESTIGATIONS, INTERVENTIONS AND TREATMENTS

Based on 'Good practice framework for consent in neonatal clinical care' produced by the British Association of Perinatal Medicine (BAPM) www.bapm.org/resources/23-consent-in-neonatal-clinical-care-good-practice-framework-2004

It is a legal and ethical requirement to gain valid consent before examining and initiating any investigation or treatment for any patient
Consent is obtained from someone with parental responsibilities:
- if married, parents
- if not married, mother but not father, unless father has acquired parental responsibility via a court order, being registered on birth certificate or parental responsibility agreement
- a legally appointed guardian
- a local authority designated in a care order or holding an emergency protection order
Consent is valid only when information has been understood by the parents and explains why the intervention is recommended, its risks and implications, and other options should consent be withheld

Documentation of information given and parents’ understanding and agreement to
proceed is the most important validation of consent. A signature does not in itself confirm informed consent

Witness consent wherever possible, and record name of witness
In neonatal practice, there are frequent occasions when no one is available to provide valid consent and treatment is initiated in its absence (e.g. emergency ABC resuscitation, stabilisation, chest drainage or exchange transfusion when delayed treatment would not be in baby’s best interests, or following maternal general anaesthetic when mother is unmarried to baby’s father). It should always be possible later to justify the action to the parents and to reassure them that it was in the baby’s best interests

GOOD PRACTICE

Give parents of babies admitted to NNU written information (BLISS https://www.bliss.org.uk/health-professionals/information-and-resources/resources-for-parents) describing low-risk procedures such as venesection, for which explicit consent is not normally sought
Give parents information leaflet for data collection, allowing them to opt out
Procedures that need to be done as an emergency may still carry risk and parents need to be fully informed about them and the likelihood of repeat procedure at the first suitable opportunity

Procedure	Explicit consent not USUALLY required	Explicit consent recommended
Examination and investigations
Examining and assessment of the patient	X
Clinical photographs and video-recordings		X
Routine blood sampling	X
Blood culture	X
Lumbar puncture:
diagnostic	X
therapeutic		X
Supra-pubic aspiration of urine	X
Screening of babies and/or their mothers in high-risk situations with no prior knowledge of maternal status e.g. suspected HIV or substance abuse		X
Screening for infection in response to positive results of maternal screening e.g. known maternal HIV or substance abuse	X
CMV, toxoplasma, rubella and herpes screening	X
Genetic testing (including karyotype)		X
Portable X-rays and ultrasounds	X
Gastrointestinal imaging involving contrast		X
Procedures involving the baby leaving the unit
X-rays	X
ultrasound	X
videoflouroscopy	X
MRI/CT with or without contrast		X
EEG/CFAM	X
EEG with video recording		X
ECG	X
ROP screening	X
Practical procedures
All surgical procedures		X
Umbilical arterial or venous catheterisation	X
Percutaneous arterial lines	Radial, ulnar or pedal	Brachial or femoral
Percutaneous long lines (including use of contrast medium to visualise tip)	X
Peripheral venous lines	X
Nasogastric/nasojejunal tubes	X
Tracheal intubation	X
Ventilation/CPAP	X
Chest drain insertion and replacement		These procedures usually need to be done as an emergency. However, they carry risk and parents need to be fully informed about them and the likelihood of repeat procedure at the first suitable opportunity	X
Abdominal drainage for perforation of ascites			X
Irrigation following extravasation injury			X
Urethral catheterisation	X
Peritoneal dialysis		X
Bone marrow aspiration		X
Any biopsy		X
Treatments
Blood transfusion	X
Use of pooled blood products	X
Exchange transfusion		X
Partial exchange transfusion	X
Antibiotics	X
Vitamins/mineral supplements	X
IV fluids	X
Parenteral nutrition	X
Surfactant	X
Anticonvulsants	X
Sedation for intubation and ventilation	X
Inotropes	X
Indomethacin or ibuprofen for patent ductus arteriosus	X
Prophylactic indomethacin	X
Parenteral and oral vitamin K for babies admitted to NNU	X
Vitamin K for normal term babies		X
Nitric oxide for term babies	X
Nitric oxide for preterm babies		X
Dexamethasone for chronic lung disease		X
Postnatal dexamethasone for laryngeal oedema	X
Immunisation		X
Treatment for retinopathy of prematurity		X
Nutrition
Breast milk fortification	X
Use of donor breast milk		X

Others: Implicit consent

Where the nature and risk of the procedure is such that a less formal transfer of information is considered sufficient, and is often retrospective
List of investigations, procedures and treatments is long
If unsure, seek senior advice

Explain all investigations, procedures and treatments to parents at earliest opportunity

DOCUMENTATION

Documentation, supported by a signature for written explicit consent
Documentation of oral explicit consent
Provide parents with information sheets

Parental consent for inclusion of neonates into participating research projects must comply with project description. Study approvals etc. for the participating unit to be overseen by relevant research and development team of NNU’s Trust

See Guideline Supporting Information

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