Table 1.
Infant demographics
| Morphine (n=15) | Placebo (n=15) | ||
|---|---|---|---|
| Characteristics at birth | |||
| Gestational age (weeks)*† | 28·1 (26·3–30·1) | 28·6 (27·9–29·7) | |
| Birthweight (g) | 1107 (329) | 1173 (350) | |
| Birthweight Z-score | −0·4 (0·9) | −0·2 (1·0) | |
| Intrauterine growth restriction* | 2 (13%) | 3 (20%) | |
| Apgar score at 10 min‡ | 10·0 (9·0–10·0) | 10·0 (8·0–10·0) | |
| Mode of delivery | |||
| Spontaneous vaginal delivery | 8 (53%) | 5 (33%) | |
| Caesarean section | 7 (47%) | 10 (67%) | |
| Male sex | 12 (80%) | 8 (53%) | |
| Female sex | 3 (20%) | 7 (47%) | |
| Multiple pregnancy | 4 (27%) | 4 (27%) | |
| Characteristics at time of randomisation | |||
| Gestational age (weeks)*† | 34·7 (34·1–35·1) | 34·7 (34·1–35·1) | |
| Time on ventilation (days)*§ | 8·0 (1·0–20·0) | 3·5 (2·0–19·5) | |
| Time since morphine last given (days)*¶ | 46·5 (33·5–49·0) | 19·0 (15·0–39·0) | |
| Presence of gastric tube* | 14 (93%) | 15 (100%) | |
| Intraventricular haemorrhage (grade I or II) | 3 (20%) | 2 (13%) | |
| History of surgery* | 0 (0%) | 1 (7%) | |
| Characteristics at time of clinical procedure | |||
| Gestational age (weeks)† | 35·0 (34·3–35·4) | 34·9 (34·3–36·3) | |
| Postnatal age (days) | 50 (28–58) | 49 (43–59) | |
| Weight (g) | 2049 (426) | 2127 (331) | |
| Duration of ROP screening (s) | 97 (82–108) | 91 (83–110) | |
| Diagnosis of ROP | 2 (13%) | 2 (13%) | |
| Level of care | |||
| Intensive care unit | 1 (7%) | 1 (7%) | |
| High-dependency unit | 5 (33%) | 9 (60%) | |
| Low-dependency unit | 9 (60%) | 5 (33%) | |
| Respiratory support modality | |||
| Self-ventilating | 9 (60%) | 8 (53%) | |
| Low-flow oxygen therapy | 2 (13%) | 1 (7%) | |
| High-flow oxygen therapy | 4 (27%) | 6 (40%) | |
| Time between IMP administration and heel lance (min) | 61 (57–66) | 63 (58–70) | |
Data are median (IQR), mean (SD), or number (%). IMP=investigational medicinal product. ROP=retinopathy of prematurity.
*
Criteria used in minimisation algorithm for randomisation.
†
Postmenstrual age is often used in neonatal practice. In our unit, the infants' gestational age is recorded each day in the medical and nursing notes; therefore, we have used this nomenclature.
‡
Data are for 15 infants in the morphine group and 13 in the placebo group.
§
Data are for six infants in the morphine group and 12 in the placebo group.
¶
Data are for four infants in the morphine group who previously received morphine and seven in the placebo group.