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. 2016 Sep 20;2016(9):CD009720. doi: 10.1002/14651858.CD009720.pub2

Gaebler 1996.

Methods Country: USA
RCT
Random sequence generation: no information
Allocation concealment: no information
Blinding of personnel delivering the intervention: no
Blinding of outcome assessors: no
Participants 18 participants
Experimental group: N = 9 (6 male/3 female/9 Caucasian), mean birth age (range) 32.3 weeks GA (30 to 34), age (range) at start of study 34.3 weeks PCA (32 to 36), mean (range) birth weight 1836 (1605 to 2282) grams
Control group: N = 9 (6 male/3 female/8 Caucasian/1 Black‐Caucasion), mean birth age (range) 32.4 weeks GA (31‐34), age (range) at start of study 34.1 weeks PCA (33 to 36), mean (range) birth weight 1729 (1410 to 1975) grams
Interventions NPIA was administered within 24 hours of entry to study, between 30 and 90 minutes before a scheduled feeding by 1 of 4 occupational or physical therapists. Recommendations were made to nursing staff. Then all parents and nurses were provided with information regarding a 5‐minute stroking protocol.
Parents of the experimental group were given further separate instruction about a 2‐minute oral motor protocol. They were instructed to carry it out 3 times a day, 5 days a week, before feedings, only until infants were nipple feeding all of their feedings for 24 hours. Parents were instructed to feed infants after they had administered the prefeeding protocol (stroking protocol or stroking, perioral and intraoral protocol). If parents were not able to administer the protocol, nursing staff did so. R‐NOMAS was administered within 48 hours of first nipple feed, then again on the following third and fifth days. They were discharged from the study once the infant managed all feeds orally for 24 hours.
All protocols were to be carried out 5 minutes before feeding, 3 times a day for 5 days.
Control group carried out a stroking protocol only, involving stroking baby in the isolette on back of head, across neck and shoulders, down head, down legs and down arms, 5 minutes before scheduled feeding. Experimental group was instructed to do the stroking protocol, then a 2‐minute oral motor stimulation protocol. Oral stimulation protocol was to take place outside the isolette if the infant was to be held for the feeding, otherwise inside the isolette.
Outcomes
  • % nipple feeds engaged in

  • R‐NOMAS scores at assessment 1, day 3 and day 5

  • Discharge from hospital (days)

  • Days in study

  • Intake for first 5 minutes of nutritive sucking on third and fifth days of R‐NOMAS testing

  • Between‐group maturation/age

  • Number of prefeeding protocols

Notes Adverse effects and unwanted symptoms were not reported.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No details were provided about how infants were assigned to either group.
Allocation concealment (selection bias) Unclear risk No information was provided.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Protocols were posted on the isolettes, so therapists and nursing staff were aware of group assignments.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Outcome assessors were 1 of the 4 researchers; all were aware of group assignments, as above.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All outcome data were provided for all infants.
Selective reporting (reporting bias) Low risk All of the study’s prespecified outcomes and all expected outcomes of interest to the review have been reported. No data were missing.
Other bias High risk Parents were instructed to feed infants after they had administered the prefeeding protocol and to hold infants in a supported, flexed position for all feedings ‐ nipple or gavage ‐ to facilitate active sucking. This could have had an influence on ability to suck and feed, thereby introducing bias. Additionally, both parents and nursing staff/researchers carried out the interventions, which may have added variability in delivery of interventions.